Fluticasone propionate

also known as Flixotide · Flonase · FLOVENT · fluticasone · Flixonase · Flixotide Evohaler · Flovent Diskus · PF-00241939 · +21 more

Other / unclassified

Developed for: asthma · chronic obstructive pulmonary disease · allergic rhinitis · seasonal allergic rhinitis · eosinophilic esophagitis · atopic eczema · childhood onset asthma · chronic asthma
+26 more
· chronic rhinosinusitis · nasal cavity polyp · perennial allergic rhinitis · transplant-related bronchiolitis obliterans · allergic contact dermatitis · blepharitis · bronchiolitis · bronchogenic carcinoma · COVID-19 · environmental induced asthma · exercise-induced bronchoconstriction · hypersensitivity reaction disease · laryngeal disorder · lung disorder · osteoarthritis, knee · polyp of vocal cord · rhinitis · skin disorder · vitiligo · allergic asthma · bronchitis · conjunctivitis · eustachian tube disorder · intermittent asthma · lower respiratory tract disorder · obstructive lung disease
Investigated by: GlaxoSmithKline · Teva Branded Pharmaceutical Products R&D, Inc. · Dey · Pfizer · Children's Hospital Medical Center, Cincinnati · National Heart, Lung, and Blood Institute (NHLBI)
+99 more
· Optinose US Inc. · SkyePharma AG · Boehringer Ingelheim · Milton S. Hershey Medical Center · Novartis Pharmaceuticals · Teva Pharmaceuticals USA · Abbott · Actavis Inc. · Brian J Lipworth · Ellodi Pharmaceuticals, LP · Fraunhofer-Institute of Toxicology and Experimental Medicine · Mundipharma Research Limited · National Institute of Allergy and Infectious Diseases (NIAID) · Respirent Pharmaceuticals Co Ltd. · The Netherlands Asthma Foundation · University of Chicago · University of Dundee · University of Florida · University of Miami · Academisch Ziekenhuis Groningen · Allergy Centre Vienna West · Amsterdam UMC, location VUmc · Assaf-Harofeh Medical Center · Assistance Publique - Hôpitaux de Paris · AstraZeneca · Bausch & Lomb Incorporated · Bayer · Becro Ltd. · Benha University · Chiesi Farmaceutici S.p.A. · Childhood Asthma Research and Education Network · Children's Hospital of Fudan University · Cipla Ltd. · Dutch Health Care Insurance Board · Egalet Ltd · Eupraxia Pharmaceuticals Inc. · Fougera Pharmaceuticals Inc. · Glenmark Pharmaceuticals Ltd. India · Guy's and St Thomas' NHS Foundation Trust · HALEON · Harvard School of Public Health (HSPH) · Henan University of Traditional Chinese Medicine · Imperial College London · Inje University · Joseph Dohar, MD · Kari Nadeau, MD, PhD · Kindeva Drug Delivery · King Edward Medical University · King's College London · Leiden University Medical Center · Libbs Farmacêutica LTDA · M.D. Anderson Cancer Center · Marc Rothenberg · Marc Rothenberg, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre · Meda Pharmaceuticals · Medical University of Vienna · Mylan Pharma UK Ltd. · National Cancer Institute (NCI) · National Center for Advancing Translational Sciences (NCATS) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Jewish Health · National Natural Science Foundation of China · Neothetics, Inc · Netherlands Institute for Pigment Disorders · Netherlands Organisation for Scientific Research · Nicox Ophthalmics, Inc. · Office of Rare Diseases (ORD) · Organon and Co · Oriel Therapeutics · Orion Corporation, Orion Pharma · PPD Development, LP · Pamukkale University · Patient-Centered Outcomes Research Institute · all 105 on the full record

Regulatory milestones approvals, filings & regulatory actions · 14 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed asthma 1 milestone
Filed	US (FDA)	—	asthma	2016-06-28	“The NDAs for fluticasone propionate/salmeterol RespiClick and fluticasone propionate RespiClick have been accepted by the FDA for standard review” tevapharm.com ↗
Approved Indication not stated 7 milestones
Label expansion	US (FDA)	XHANCE	—	2024-03-15	fda.gov ↗
Label expansion	US (FDA)	ARMONAIR RESPICLICK	—	2021-07-09	fda.gov ↗
Approved	EU (EMA)	Aerivio Spiromax	—	2016-08-18	europa.eu ↗
Label expansions (4)	US (FDA)	CUTIVATE	—	1997-04-25 – 2015-01-16	fda.gov ↗
Label expansion	US (FDA)	FLOVENT HFA	—	2006-02-28	fda.gov ↗
Label expansions (4)	US (FDA)	FLONASE	—	1997-10-31 – 2003-05-01	fda.gov ↗
Approved	US (FDA)	CUTIVATE	—	1990-12-14	fda.gov ↗

Trials 180 · started per year

today

US approved 1990

EU approved 2016

199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT03594565	Mar 2016 → Jun 2017	hypersensitivity reaction disease, type 1 diabetes mellitus	Assaf-Harofeh Medical Center	Completed	No outcome recorded
Phase 124 trials · 2 met primary
Phase 1	NCT06290102	May → Oct 2024	asthma	Teva Branded Pharmaceutical Products R&D, Inc.	Completed	No outcome recorded
Phase 1	NCT03040596	Mar 2017 → Jan 2019	polyp of vocal cord	Joseph Dohar, MD	Terminated	No outcome recorded
Phase 1	NCT02609126	Apr 2016 → Dec 2017	osteoarthritis, knee	Eupraxia Pharmaceuticals Inc.	Completed	No outcome recorded
Phase 1	NCT02680561	Apr → Jun 2016	asthma	Teva Branded Pharmaceutical Products R&D, Inc.	Completed	No outcome recorded
Phase 1	NCT02437604	May → Jul 2015	asthma	Teva Branded Pharmaceutical Products R&D, Inc.	Completed	No outcome recorded
Phase 1	NCT02218762	Oct 2014 → Jun 2015	asthma	GlaxoSmithKline	Withdrawn	No outcome recorded
Phase 1	NCT02266927	Sep 2014 → Mar 2015	asthma	Optinose US Inc.	Completed	No outcome recorded
Phase 1	NCT02260492	Sep 2014 → May 2015	asthma	Oriel Therapeutics	Completed	Met primary
Phase 1	NCT02232087	Jul → Oct 2014	—	Kindeva Drug Delivery	Completed	Met primary
Phase 1	NCT01890863	Aug → Sep 2013	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01564199	Apr → Jun 2012	—	Orion Corporation, Orion Pharma	Completed	No outcome recorded
Phase 1	NCT01540708	Jan → Sep 2012	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01449799	Jul → Sep 2011	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01364519	Jul 2011 → Jan 2012	chronic obstructive pulmonary disease	Pfizer	Completed	No outcome recorded
Phase 1	NCT01181700	Oct 2010 → Jan 2011	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT01064726	Oct 2009 → Apr 2010	allergic rhinitis	Pfizer	Completed	No outcome recorded
Phase 1	NCT00867282	Jun → Jul 2009	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT00862667	May → Jun 2009	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT00657774	Apr → Sep 2008	asthma	SkyePharma AG	Completed	No outcome recorded
Phase 1	NCT01365611	Feb → May 2007	—	Egalet Ltd	Completed	No outcome recorded
Phase 1	NCT00370097	Aug 2006 → Apr 2007	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00348361	Apr 2005 → ?	allergic rhinitis	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00364442	Jan → Apr 2005	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00280358	? → Dec 2005	—	Dey	Completed	No outcome recorded

Phase 1/21 trial
Phase 1/2	NCT01494610	Oct 2010 → Jun 2011	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 223 trials · 6 met primary · 1 missed
Phase 2	NCT03742414	Jun 2021 → May 2028 expected	atopic eczema	Kari Nadeau, MD, PhD	Active not recruiting	No outcome recorded
Phase 2	NCT06051786	Aug 2020 → Jul 2021	allergic rhinitis	Synmosa Biopharma Corp.	Completed	No outcome recorded
Phase 2	NCT03926026	Mar → Oct 2019	blepharitis	Nicox Ophthalmics, Inc.	Completed	Met primary
Phase 2	NCT04179461	Mar 2018 → Oct 2019	childhood onset asthma	Children's Hospital Medical Center, Cincinnati	Completed	No outcome recorded
Phase 2	NCT02991859	Feb 2017 → Dec 2018	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT01576718	Apr 2012 → Jul 2013	asthma	Teva Branded Pharmaceutical Products R&D, Inc.	Completed	Missed primary
Phase 2	NCT01516086	Mar 2012 → Nov 2013	asthma	Dey	Completed	No outcome recorded
Phase 2	NCT01516073	Mar 2012 → Nov 2013	asthma	Dey	Completed	No outcome recorded
Phase 2	NCT01479621	Jan 2012 → Jul 2013	asthma	Teva Branded Pharmaceutical Products R&D, Inc.	Completed	Met primary
Phase 2	NCT01578278	Dec 2011 → Aug 2012	seasonal allergic rhinitis	Bausch & Lomb Incorporated	Completed	No outcome recorded
Phase 2	NCT01712451	Aug 2011 → Oct 2012	—	Neothetics, Inc	Completed	No outcome recorded
Phase 2	NCT01307462	Jun 2011 → Sep 2014	transplant-related bronchiolitis obliterans	Stephanie Lee	Completed	Met primary
Phase 2	NCT01424397	Apr → Jul 2011	rhinitis	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT01253603	Nov 2010 → Sep 2011	chronic asthma	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01168310	Aug 2010	chronic obstructive pulmonary disease	Dey	Completed	No outcome recorded
Phase 2	NCT01007721	Oct 2009 → Apr 2010	asthma, seasonal allergic rhinitis	Boehringer Ingelheim	Completed	Met primary
Phase 2	NCT00656916	Mar 2008 → Dec 2010	bronchiolitis	M.D. Anderson Cancer Center	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00612820	Jan → May 2008	seasonal allergic rhinitis	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00426283	Jan 2007 → Dec 2011	eosinophilic esophagitis	Marc Rothenberg, MD	Completed	Met primary
Phase 2	NCT00403286	Nov 2006 → May 2007	chronic obstructive pulmonary disease	Dey	Completed	No outcome recorded
Phase 2	NCT00325169	Dec 2005 → Aug 2006	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 2	NCT00400855	Jan → Aug 2005	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00407264	Feb 2002 → Dec 2005	bronchogenic carcinoma	Amsterdam UMC, location VUmc	Completed	No outcome recorded

Phase 2/34 trials · 1 missed
Phase 2/3	NCT05535738	Nov 2022 → Jan 2027 expected	allergic contact dermatitis	Wei-Che Ko	Active not recruiting	No outcome recorded
Phase 2/3	NCT05054322	Sep 2021 → Jan 2022	COVID-19	University of Medicine and Pharmacy at Ho Chi Minh City	Unknown	No outcome recorded
Phase 2/3	NCT02778867	May 2016 → Apr 2019	eosinophilic esophagitis	Children's Hospital Medical Center, Cincinnati	Completed	Missed primary
Phase 2/3	NCT02610816	Mar 2016 → May 2018	eosinophilic esophagitis	Children's Hospital Medical Center, Cincinnati	Completed	No outcome recorded
Phase 355 trials · 13 met primary · 1 missed
Phase 3	NCT05776927	Aug 2026 → Dec 2028 expected	asthma	Novartis Pharmaceuticals	Recruiting	No outcome recorded
Phase 3	NCT06664619	Dec 2024 → Nov 2026 expected	asthma	Teva Branded Pharmaceutical Products R&D, Inc.	Active not recruiting	No outcome recorded
Phase 3	NCT06052267	Aug 2023 → Oct 2026 expected	asthma	Teva Branded Pharmaceutical Products R&D, Inc.	Active not recruiting	No outcome recorded
Phase 3	NCT05634746	Dec 2022 → Aug 2024	eosinophilic esophagitis	Ellodi Pharmaceuticals, LP	Completed	No outcome recorded
Phase 3	NCT05363202	Apr 2022 → May 2024	asthma	Glenmark Pharmaceuticals Ltd. India	Unknown	No outcome recorded
Phase 3	NCT05083312	Sep 2021 → Sep 2022	eosinophilic esophagitis	Ellodi Pharmaceuticals, LP	Completed	No outcome recorded
Phase 3	NCT04655508	May 2021 → Sep 2023	disease related to hematopoietic stem cell transplant, transplant-related bronchiolitis obliterans	Assistance Publique - Hôpitaux de Paris	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT04665895	Dec 2020 → Aug 2021	asthma	Respirent Pharmaceuticals Co Ltd.	Completed	No outcome recorded
Phase 3	NCT03879837	Mar 2019 → May 2021	asthma	Actavis Inc.	Completed	No outcome recorded
Phase 3	NCT03394989	Oct 2018 → Dec 2019	asthma	Cipla Ltd.	Completed	No outcome recorded
Phase 3	NCT03676413	Oct 2018 → Aug 2019	asthma	Respirent Pharmaceuticals Co Ltd.	Completed	No outcome recorded
Phase 3	NCT03591068	Jun 2018 → Feb 2019	nasal cavity polyp	Optinose US Inc.	Completed	No outcome recorded
Phase 3	NCT03169504	May 2017 → May 2018	chronic obstructive pulmonary disease	Henan University of Traditional Chinese Medicine	Unknown	Mixed
Phase 3	NCT02980133	Dec 2016 → Apr 2019	asthma	Teva Branded Pharmaceutical Products R&D, Inc.	Completed	Mixed
Phase 3	NCT02924688	Oct 2016 → Feb 2019	asthma	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT02496715	Sep 2015 → Oct 2016	asthma	Actavis Inc.	Withdrawn	No outcome recorded
Phase 3	NCT02301975	Mar 2015 → Nov 2016	asthma	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT02523820	Jan 2015 → May 2016	laryngeal disorder	Ramathibodi Hospital	Completed	Missed primary
Phase 3	NCT02245672	Oct 2014 → Jul 2015	asthma	Mylan Pharma UK Ltd.	Completed	Met primary
Phase 3	NCT02249663	Aug 2014 → Feb 2015	seasonal allergic rhinitis	Teva Pharmaceuticals USA	Unknown	No outcome recorded
Phase 3	NCT04332978	Jul 2014 → Apr 2020	perennial allergic rhinitis	Libbs Farmacêutica LTDA	Completed	No outcome recorded
Phase 3	NCT02175771	Jul 2014 → Jul 2015	asthma	Teva Branded Pharmaceutical Products R&D, Inc.	Completed	Met primary
Phase 3	NCT02141854	Jun 2014 → Sep 2015	asthma	Teva Branded Pharmaceutical Products R&D, Inc.	Completed	Met primary
Phase 3	NCT02139644	Jun 2014 → Sep 2015	asthma	Teva Branded Pharmaceutical Products R&D, Inc.	Completed	Met primary
Phase 3	NCT02094937	Mar 2014 → Aug 2015	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT02246920	Mar → Jul 2014	seasonal allergic rhinitis	Teva Pharmaceuticals USA	Terminated	No outcome recorded
Phase 3	NCT01967173	Feb 2014 → Jul 2017	asthma	Milton S. Hershey Medical Center	Completed	Mixed
Phase 3	NCT01978145	Nov 2013 → Apr 2015	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01978119	Nov 2013 → Jan 2015	asthma	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01946620	Oct 2013 → Apr 2016	chronic obstructive pulmonary disease	Mundipharma Research Limited	Completed	No outcome recorded
Phase 3	NCT01623323	Sep 2013 → Mar 2015	chronic rhinosinusitis	Optinose US Inc.	Completed	No outcome recorded
Phase 3	NCT01623310	Sep 2013 → Aug 2015	nasal cavity polyp	Optinose US Inc.	Completed	No outcome recorded
Phase 3	NCT01606306	Feb 2013 → Apr 2015	asthma	Milton S. Hershey Medical Center	Completed	Met primary
Phase 3	NCT01817790	Dec 2012 → Feb 2013	seasonal allergic rhinitis	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01687296	Nov 2012 → Jun 2013	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT01687283	Sep 2012 → Nov 2013	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00883168	Apr → Jul 2009	seasonal allergic rhinitis	Meda Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00747318	Sep 2008 → May 2010	asthma	SkyePharma AG	Completed	No outcome recorded
Phase 3	NCT00449046	Mar → Nov 2007	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00395304	Mar 2007 → Dec 2011	asthma	Milton S. Hershey Medical Center	Completed	Met primary
Phase 3	NCT00475813	Mar 2007 → Feb 2008	asthma	Mundipharma Research Limited	Completed	No outcome recorded
Phase 3	NCT00441441	Feb 2007 → Jan 2008	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00411372	Nov 2006 → ?	chronic obstructive pulmonary disease	GlaxoSmithKline	Withdrawn	No outcome recorded Stop: Enrollment
Phase 3	NCT00394199	Jun 2006 → Feb 2008	asthma	SkyePharma AG	Completed	Met primary
Phase 3	NCT00394121	Mar 2006 → Jul 2007	asthma	SkyePharma AG	Completed	No outcome recorded
Phase 3	NCT00328718	Oct 2005 → Apr 2007	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00269126	Feb → Aug 2005	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00394368	Nov 2004 → Sep 2005	asthma	Chiesi Farmaceutici S.p.A.	Completed	Met primary
Phase 3	NCT00549146	Nov 2003 → Apr 2006	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00268177	Oct 2002 → Dec 2003	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00266578	Oct 2002 → Nov 2006	eosinophilic esophagitis	Marc Rothenberg	Completed	No outcome recorded
Phase 3	NCT00920959	Nov 2001 → Jan 2004	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00489346	Oct 2001 → Jun 2002	asthma	Organon and Co	Completed	No outcome recorded
Phase 3	NCT00268216	Sep 2000 → Nov 2005	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00158834	Nov 1999 → ?	asthma	GlaxoSmithKline	Completed	No outcome recorded

Phase 463 trials · 12 met primary · 11 missed
Phase 4	NCT07664527	Nov 2026 → Sep 2027 expected	asthma	University of Wisconsin, Madison	Not yet recruiting	No outcome recorded
Phase 4	NCT07817134	Sep → Dec 2026 expected	seasonal allergic rhinitis	HALEON	Not yet recruiting	No outcome recorded
Phase 4	NCT07675252	Aug 2026 → May 2027 expected	—	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Not yet recruiting	No outcome recorded
Phase 4	NCT06858423	Aug 2023 → Mar 2024	allergic rhinitis	Benha University	Completed	No outcome recorded
Phase 4	NCT07415278	Dec 2022 → Oct 2023 overdue	allergic rhinitis	Pamukkale University	Active not recruiting	No outcome recorded
Phase 4	NCT05444543	Nov 2021 → Oct 2023	eosinophilic esophagitis	University Hospitals Cleveland Medical Center	Completed	Missed primary
Phase 4	NCT04527016	Oct 2021 → Jun 2023	childhood onset asthma	Children's Hospital of Fudan University	Completed	No outcome recorded
Phase 4	NCT05080322	Sep 2021 → Dec 2025	allergic rhinitis	Zheng Liu ENT	Completed	No outcome recorded
Phase 4	NCT04677959	Feb 2021 → Mar 2022	asthma	Teva Branded Pharmaceutical Products R&D, Inc.	Completed	No outcome recorded
Phase 4	NCT04601324	Dec 2020 → Jun 2021	allergic rhinitis	St. Paul's Sinus Centre	Withdrawn	No outcome recorded
Phase 4	NCT04957927	Dec 2020 → Sep 2021	allergic rhinitis	Usama Azhar	Unknown	No outcome recorded
Phase 4	NCT03443843	Feb → May 2018	allergic rhinitis	Bayer	Completed	No outcome recorded
Phase 4	NCT02730351	May 2016 → Feb 2017	asthma	GlaxoSmithKline	Completed	Missed primary
Phase 4	NCT02402465	Feb 2015 → Mar 2018	allergic rhinitis	University of Chicago	Completed	Missed primary
Phase 4	NCT02113436	May 2014 → Jun 2016	asthma	GlaxoSmithKline	Completed	Missed primary
Phase 4	NCT01915914	Dec 2013 → Feb 2015	skin disorder	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT01916226	Aug → Oct 2013	allergic rhinitis	GlaxoSmithKline	Completed	Missed primary
Phase 4	NCT01845025	May 2013 → May 2016	chronic asthma	Novartis Pharmaceuticals	Terminated	No outcome recorded
Phase 4	NCT01554488	Mar 2013 → Feb 2016	asthma, chronic obstructive pulmonary disease, obstructive sleep apnea syndrome	VA Office of Research and Development	Terminated	Missed primary Stop: Enrollment
Phase 4	NCT01762800	Feb 2013 → Sep 2015	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT01607398	May 2012 → Jul 2013	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Missed primary
Phase 4	NCT01124422	Jul 2010 → May 2011	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Missed primary
Phase 4	NCT00974805	Feb 2010 → Feb 2012	chronic obstructive pulmonary disease	University of Southampton	Completed	No outcome recorded
Phase 4	NCT00984659	Oct 2009 → Jul 2010	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Mixed
Phase 4	NCT00975195	Feb 2009 → Jul 2013	chronic obstructive pulmonary disease	Boehringer Ingelheim	Completed	Met primary
Phase 4	NCT00784550	Dec 2008 → Dec 2009	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT00692978	Aug 2008 → Jul 2011	asthma	Imperial College London	Completed	No outcome recorded
Phase 4	NCT02136875	Jul 2008 → Aug 2010	chronic obstructive pulmonary disease	McGill University Health Centre/Research Institute of the McGill University Health Centre	Completed	No outcome recorded
Phase 4	NCT00487032	May 2008 → May 2009	allergic rhinitis	Brian J Lipworth	Completed	No outcome recorded
Phase 4	NCT00633217	Mar 2008 → Feb 2009	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00848965	Oct 2007 → Jan 2008	perennial allergic rhinitis	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT00517634	Aug 2007 → Jul 2008	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00546000	Jul 2007 → Dec 2008	atopic eczema	Fougera Pharmaceuticals Inc.	Completed	No outcome recorded
Phase 4	NCT00461500	Mar → Dec 2007	asthma	GlaxoSmithKline	Completed	Missed primary
Phase 4	NCT00712335	Feb 2007 → May 2011	environmental induced asthma	Inje University	Completed	No outcome recorded
Phase 4	NCT00903227	Dec 2006 → Aug 2008	allergic rhinitis, asthma	University of Dundee	Completed	Missed primary
Phase 4	NCT00346749	Dec 2006 → Jul 2007	chronic obstructive pulmonary disease	GlaxoSmithKline	Terminated	No outcome recorded
Phase 4	NCT00400608	Oct 2006 → Feb 2007	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00995475	Oct 2006 → Nov 2008	chronic obstructive pulmonary disease	University of Dundee	Completed	No outcome recorded
Phase 4	NCT00358358	Mar 2006 → Feb 2007	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00353873	Nov 2005 → Oct 2006	asthma	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT00291382	Nov 2005 → Jul 2007	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00296530	Sep 2005 → Jul 2007	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00197106	Jun 2005 → Oct 2008	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00455923	May 2005 → Jul 2007	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00115492	Dec 2004 → Jun 2007	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT00102765	Nov 2004 → Apr 2007	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00102882	Oct 2004 → Jan 2007	asthma	GlaxoSmithKline	Completed	Missed primary
Phase 4	NCT00144911	Oct 2004 → Dec 2006	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT00355342	Apr 2004 → Sep 2007	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00118716	Dec 2003 → Apr 2006	exercise-induced bronchoconstriction	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT00239421	Nov 2003 → Sep 2004	chronic obstructive pulmonary disease	Boehringer Ingelheim	Completed	Met primary
Phase 4	NCT00361959	Jun 2003 → Feb 2006	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00307970	Apr → Sep 2003	asthma	University of Florida	Completed	No outcome recorded
Phase 4	NCT00308932	Feb 2003 → Apr 2004	asthma	University of Florida	Completed	No outcome recorded
Phase 4	NCT00169546	Jan 2003 → Dec 2005	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00370591	Dec 2002 → Apr 2004	asthma	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT00479739	Nov 2002 → Jul 2004	asthma	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT00453778	Nov 2002 → May 2004	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00158847	Apr 2000 → May 2005	chronic obstructive pulmonary disease	Leiden University Medical Center	Terminated	Met primary
Phase 4	NCT00184977	Dec 1998 → Jan 2003	chronic bronchitis	Radboud University Medical Center	Completed	No outcome recorded
Phase 4	NCT01657097	Feb → Apr 1997	allergic rhinitis, asthma	University of Aarhus	Completed	No outcome recorded
Phase 4	NCT00846326	—	allergic rhinitis	Brian J Lipworth	Withdrawn	No outcome recorded

Phase not applicable9 trials · 2 met primary · 2 missed
—	NCT03524066	Apr → Dec 2018	—	Fraunhofer-Institute of Toxicology and Experimental Medicine	Completed	No outcome recorded
—	NCT02290717	May → Nov 2015	vitiligo	Netherlands Institute for Pigment Disorders	Withdrawn	No outcome recorded
—	NCT02182492	Jan 2014 → Dec 2015	chronic rhinosinusitis	Zheng Liu	Completed	No outcome recorded
—	NCT02141633	Apr 2013 → Jun 2015	—	University of Miami	Completed	No outcome recorded
—	NCT01400568	Aug 2011 → Jan 2012	—	Fraunhofer-Institute of Toxicology and Experimental Medicine	Completed	No outcome recorded
—	NCT01213693	May 2009 → May 2013	chronic obstructive pulmonary disease	Università degli Studi di Ferrara	Completed	Met primary
—	NCT01231230	May 2007 → Dec 2009	asthma	University of Miami	Completed	Met primary
—	NCT00272441	Jan 2001 → Sep 2004	asthma, lung disorder	National Heart, Lung, and Blood Institute (NHLBI)	Completed	Missed primary
—	NCT00755066	—	seasonal allergic rhinitis	Medical University of Vienna	Completed	Missed primary
Comparator or background therapy148 trials
Phase 1	NCT03112577 Comparator	Jun 2017 → Mar 2019	allergic asthma	Regeneron Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT01966692 Comparator	Nov 2016 → Jan 2018	asthma	University of Florida	Completed	No outcome recorded
Phase 1	NCT02474017 Background	May → Jun 2015	asthma, chronic obstructive pulmonary disease	Mylan Pharma UK Ltd.	Completed	No outcome recorded
Phase 1	NCT00877539 Comparator	Jun → Dec 2009	asthma	Pfizer	Completed	No outcome recorded
Phase 1	NCT00869596 Comparator	Mar → Sep 2009	lower respiratory tract disorder	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Show all 148 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 49

Date	Issuer	Release
2026-08-20	Glenmark Pharmaceuticals Ltd. India	Regulatory Glenmark Pharmaceuticals receives U.S. FDA approval for Fluticasone Propionate Nasal Spray, 0.05 mg (50 mcg)/spray glenmarkpharma.com ↗ Glenmark Pharmaceuticals Limited (Glenmark) today announced the receipt of U.S. FDA approval1 for Fluticasone Propionate Nasal Spray USP, 0.05 mg/spray.
2026-03-19	Glenmark Pharmaceuticals Ltd. India	Regulatory Glenmark Therapeutics Inc., USA launches Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC) glenmarkpharma.com ↗ Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC).
2026-03-04	Glenmark Pharmaceuticals Ltd. India	Regulatory Glenmark Specialty SA Receives U.S. FDA Approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, with 180-Day Competitive Generic Therapy Exclusivity glenmarkpharma.com ↗ Glenmark Specialty SA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation.
2021-11-30	NicOx Inc.	Results Nicox’s Positive Post Hoc Results from NCX 4251 Phase 2b Mississippi Trial Suggest Path Forward in Dry Eye Disease nicox.com ↗ The new results show that, for a subgroup of patients scoring more highly for a key sign of dry eye, statistically significant improvements in a number of dry eye symptoms and improvements in one sign (p=0.0524) were seen.
2021-09-24	NicOx Inc.	Results Nicox Announces Results from the NCX 4251 Phase 2b Mississippi Blepharitis Trial nicox.com ↗ NCX 4251 also showed a statistically significant difference against placebo in the exploratory endpoint of change from baseline in the composite score of the same key signs and symptoms at Day 8 (p=0.03), Day 11 (p=0.01) and Day 15 (p=0.01).
2021-06-01	Lannett Company, Inc.	Regulatory Lannett Announces FDA Acceptance, As A Priority Original ANDA, Of The Generic Advair Diskus® Filing investorroom.com ↗ Lannett Company, Inc. (NYSE: LCI) today announced the U.S. Food and Drug Administration (FDA) has accepted the Abbreviated New Drug Application (ANDA) for Fluticasone Propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg), which was submitted by Lannett on behalf of its strategic alliance partner, Respirent Pharmaceuticals Co. Ltd.
2021-04-01	Lannett Company, Inc.	Regulatory Lannett Submits ANDA For Generic ADVAIR DISKUS® investorroom.com ↗ Lannett Company, Inc. (NYSE: LCI) today announced the submission of an Abbreviated New Drug Application (ANDA) for Fluticasone propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg) to the U.S. Food and Drug Administration (FDA), by its strategic alliance partner, Respirent Pharmaceuticals Co. Ltd.
2020-06-05	Novartis Pharmaceuticals	Results Novartis Phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair® Breezhaler® (QVM149) versus a free combination of two existing inhaled treatments in uncontrolled asthma novartis.com ↗ Once-daily Enerzair ® Breezhaler ® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily tiotropium (Tio), in improving quality of life in people with uncontrolled asthma 1 .
2020-02-24	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Announces FDA Approval of ArmonAir® Digihaler™ (fluticasone propionate) Inhalation Powder tevapharm.com ↗ Teva Respiratory, LLC, an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ArmonAir® Digihaler™ (fluticasone propionate) Inhalation Powder, an inhaled corticosteroid (ICS) delivered via Teva’s Digihaler™ device, which contains built-in sensors and connects to a companion mobile application that provides information on inhaler use to people with asthma.
2019-07-15	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Announces FDA Approval of AirDuo® Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder tevapharm.com ↗
2019-03-12	Adare Pharmaceuticals, Inc.	Results Primary End-Point achieved in Phase IIb Study (FLUTE™) for APT-1011 adarepharmasolutions.com ↗ The study results indicate that the primary end-point was achieved, as were a number of secondary endpoints that measured patient symptoms and improvement of characteristic features of the disease.
2018-09-10	Glenmark Pharmaceuticals Ltd. India	Regulatory Glenmark secures marketing authorization in Germany for its generic version of Seretide® Accuhaler® glenmarkpharma.com ↗ announced today that its subsidiary Glenmark Arzneimittel GmbH has secured marketing authorization in Germany for Fluticasone/Salmeterol dry powder inhaler (DPI), a generic version of GlaxoSmithKline’s Seretide® Accuhaler®.
2017-11-27	Novartis Pharmaceuticals	Results Novartis' Ultibro® Breezhaler® significantly improved COPD patients' lung function after direct switch from Seretide® novartis.com ↗ Novartis today announced positive results from the FLASH** study examining the safety and efficacy of directly switching chronic obstructive pulmonary disease (COPD) patients from Seretide ® (salmeterol/fluticasone) 50/500 mcg to Ultibro ® Breezhaler ® (indacaterol/glycopyrronium) 110/50 mcg[1].
2017-09-20	GlaxoSmithKline	Results GSK and Innoviva report positive headline results from IMPACT study showing single inhaler triple therapy Trelegy Ellipta reduced COPD exacerbations gsk.com ↗
2017-06-15	Novartis Pharmaceuticals	Regulatory FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus® novartis.com ↗ Sandoz today announced that the US Food and Drug Administration (FDA) has accepted its Abbreviated New Drug Application for fluticasone propionate / salmeterol combination product, a substitutable generic version of Advair Diskus ® [1].
2017-06-14	Sun Pharma Advanced Research Company Limited	Results SPARC Announces Top-line Results of Pivotal Peak Inspiratory Flow (PIF) study and Low Dose Pharmacokinetic (PK) Study for Salmeterol – Fluticasone Dry Powder Inhaler (SPARC DPI) SPARC DPI meets the end point for PIF study In the Low dose PK study bio-equivalence established for Fluticasone, however, Salmeterol component not bio equivalent to the comparator arm sparc.life ↗ The bioavailability of 50 μg fluticasone propionate using the SPARC DPI was comparable to the administration of 100 μg fluticasone propionate using the Seretide Accuhaler® and within the acceptance range for bioequivalence.
2017-05-23	Novartis Pharmaceuticals	Results Novartis' new analyses reinforce the potential of Ultibro® Breezhaler® for COPD patients historically treated with steroids novartis.com ↗ The new data showed that Ultibro ® Breezhaler ® consistently provided superior or similar benefits over Seretide ®* in COPD patients regardless of the eosinophil count[1].
2017-02-23	GlaxoSmithKline	Results Positive results for Relvar® Ellipta® lung function study in patients with well-controlled asthma gsk.com ↗ Results demonstrated statistically significant differences in favour of the ICS/LABA combinations to FP (p<0.001).
2017-01-30	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Announces FDA Approval of Two New RespiClick® Maintenance Inhalers for the Treatment of Asthma tevapharm.com ↗
2016-09-05	Nxera Pharma UK Limited	Results New findings confirm UltibroR BreezhalerR is consistently more effective than SeretideR in reducing COPD flare-ups across different patient groups nxera.life ↗ Ultibro® Breezhaler ® reduced the rate of all COPD exacerbations across different patient sub-groups vs Seretide in new results from the FLAME study
2016-09-03	Novartis Pharmaceuticals	Results Novartis' Ultibro® Breezhaler® consistently more effective than Seretide®* in reducing COPD flare-ups across different patient groups novartis.com ↗ New analyses from the head-to-head FLAME study confirmed that Ultibro ® Breezhaler ® is a more effective option for patients at risk of chronic obstructive pulmonary disease (COPD) flare-ups (exacerbations) than Seretide ® , across different patient sub-groups[1-10].
2016-09-01	GlaxoSmithKline	Results NEJM publishes results of GSK’s long-term LABA safety study of Advair® Diskus® in children aged 4-11 years with asthma gsk.com ↗ In the study a non-statistically significant reduction of 14% was observed in the risk of time-to-first asthma exacerbation for FSC compared to FP (HR 0.859; 95% CI 0.729, 1.012).
2016-08-31	Novartis Pharmaceuticals	Results AirFluSal® Forspiro® showed superiority at 12 months over Seretide® Diskus®[1] in persistence to treatment novartis.com ↗ New study shows that rate of patient persistence using Sandoz AirFluSal Forspiro is twice as high as for reference product Seretide® Diskus®.
2016-06-28	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Announces FDA Acceptance of New Drug Applications for Fluticasone Propionate/Salmeterol and Fluticasone Propionate RespiClick® Inhalers tevapharm.com ↗ Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s new drug applications (NDAs) for two products for adolescent and adult patients with asthma.
2016-05-31	Perrigo Company	Regulatory Perrigo Announces FDA Approval And Launch Of The Store Brand Equivalent To Flonase® perrigo.com ↗
2016-05-16	Nxera Pharma UK Limited	Results Major study published in NEJM confirms Ultibro Breezhaler superiority over Seretide in preventing COPD exacerbations nxera.life ↗ Ultibro Breezhaler also significantly reduced the rate and prolonged the time to the first moderate or severe exacerbation, compared to Seretide
2016-05-15	Novartis Pharmaceuticals	Results Major study published in NEJM confirms Novartis' Ultibro® Breezhaler® superiority over Seretide® in preventing COPD exacerbations novartis.com ↗ In addition to meeting the primary endpoint (non-inferiority), findings demonstrated the superiority of Ultibro Breezhaler over the widely used inhaled corticosteroid (ICS)/LABA* combination on exacerbation outcomes[1].
2016-03-17	GlaxoSmithKline	Results GSK’s Advair® Diskus® achieves primary endpoint in LABA safety study of children aged 4-11 years with asthma gsk.com ↗ The primary safety endpoint of the study showed FSC twice-daily (100/50mcg, 250/50mcg) demonstrated non-inferiority compared to corresponding doses of FP twice-daily (100mcg, 250mcg), on the risk of serious asthma-related events, Hazard Ratio (HR) 1.285, (95% CI 0.726, 2.272) p=0.006.
2016-02-09	Boehringer Ingelheim	Results Newly Published Head-to-Head Data Show STIOLTO RESPIMAT Improved Lung Function Across Range of Measures prnewswire.com ↗ These newly published data show a lung function improvement among COPD patients with STIOLTO RESPIMAT across a range of commonly used measures of lung function.
2015-11-24	Niox	Regulatory Circassia Announces Positive Outcome of European Decentralised Procedure for Approval of Its Fluticasone Propionate Equivalent of GSK’s FLIXOTIDE® pMDI niox.com ↗ Circassia Pharmaceuticals plc (LSE: CIR) today announces the positive outcome of the European Decentralised Procedure (DCP) for the Company’s fluticasone propionate pressurised metered dose inhaler (pMDI) generic equivalent of GlaxoSmithKline’s FLIXOTIDE® pMDI for the prophylactic treatment of asthma.
2015-11-19	Teva Branded Pharmaceutical Products R&D, Inc.	Results Teva Reports Positive Top-Line Results from Phase III Trials Evaluating Fluticasone Propionate/Salmeterol and Fluticasone Propionate Multidose Dry Powder Inhalers (MDPIs) in Patients with Asthma tevapharm.com ↗ Top-line data showed that the studies met their primary endpoints.
2015-11-17	Nxera Pharma UK Limited	Results FLAME Study Shows Superiority of Ultibro Breezhaler over Seretide in Reducing COPD Exacerbations nxera.life ↗
2015-10-27	GlaxoSmithKline	Results GSK’s Advair® Diskus® achieves primary endpoint in LABA safety study of patients with asthma gsk.com ↗ No asthma-related deaths were seen in either arm of the study.
2015-09-28	Boehringer Ingelheim	Results New Head-to-Head STIOLTO RESPIMAT Data Presented at ERS Annual Congress prnewswire.com ↗ The results from the head-to-head ENERGITO® study build on the growing body of evidence supporting the ability of STIOLTO RESPIMAT to improve lung function in COPD patients.
2015-05-19	GlaxoSmithKline	Results GSK presents data at ATS on the role of blood eosinophil levels as a potential biomarker in the treatment of COPD gsk.com ↗ GSK today presented two abstracts at the American Thoracic Society (ATS) meeting that provide data on the role of blood eosinophils as a potential biomarker to determine responsiveness to treatment with an inhaled corticosteroid (ICS) in patients with COPD.
2014-10-17	GlaxoSmithKline	Results Data published on Anoro® Ellipta® demonstrate improved lung function compared to tiotropium gsk.com ↗
2014-09-08	Boehringer Ingelheim	Results Boehringer Ingelheim Presents Pivotal Phase III Data for the Investigational Fixed-Dose Combination of Tiotropium + Olodaterol in COPD prnewswire.com ↗ Also presented at ERS for the first time, were data from the 52-week WISDOM (Withdrawal of Inhaled Steroids During Optimised bronchodilator Management) trial.
2014-09-08	GlaxoSmithKline	Results GSK data presented at ERS demonstrate potential of blood eosinophil levels to help inform COPD treatment decisions gsk.com ↗
2014-09-08	Nxera Pharma UK Limited	Results Positive results from three clinical trials presented at ERS 2014 further confirmed efficacy of Ultibro Breezhaler and Seebri Breezhaler, and promotion agreement with Pfizer in the UK nxera.life ↗
2014-07-24	GlaxoSmithKline	Regulatory FDA approves Flonase allergy relief for sale over-the-counter in the United States gsk.com ↗
2014-07-04	GlaxoSmithKline	Regulatory Anoro® Ellipta® (umeclidinium/vilanterol) gains approval in Japan for the treatment of COPD gsk.com ↗
2014-05-19	GlaxoSmithKline	Results GSK presents positive data at ATS 2014 from study evaluating efficacy and safety of Incruse™ Ellipta® added to Advair® Diskus® in patients with COPD gsk.com ↗
2014-04-30	Nxera Pharma UK Limited	Results Once-daily Ultibro Breezhaler showed superior efficacy versus Seretide for COPD patients in second head-to-head study, and the anticipated timing of China filing nxera.life ↗ Ultibro® Breezhaler® demonstrated superiority in lung function compared to Seretide® Accuhaler®* in chronic obstructive pulmonary disease (COPD) patients with or without exacerbations in the previous year
2014-03-14	GlaxoSmithKline	Results GSK and Theravance announce positive results from studies comparing ANORO™ ELLIPTA™ with SERETIDE® DISKUS® and ADVAIR® DISKUS® in patients with COPD gsk.com ↗ UMEC/VI achieved a statistically significant improvement in lung function
2013-07-31	Perrigo Company	Regulatory Perrigo Announces FDA Final Approval For Generic Equivalent To Cutivate® Lotion, 0.05% perrigo.com ↗ Perrigo Company (NYSE: PRGO; TASE) today announced that it has received final approval for its abbreviated new drug application for fluticasone propionate lotion, 0.05%, the generic equivalent to Cutivate® Lotion, 0.05%.
2012-03-23	GlaxoSmithKline	Results GSK and Theravance announce completion of the Relovair™* registrational programme and topline results from Relovair™ vs. Advair® phase III studies in COPD gsk.com ↗ In addition, results from two studies for the once-daily investigational medicine Relovair™ (fluticasone furoate “FF”/vilanterol “VI” (FF/VI)) in patients with chronic obstructive pulmonary disease (COPD) and results from a study to evaluate the efficacy and safety of FF and FP (fluticasone propionate) compared to placebo in the treatment of persistent asthma in adults and adolescents were announced.
2010-06-01	GlaxoSmithKline	Regulatory GSK announces revised product labels for Serevent and Advair gsk.com ↗ today announced that it has received a letter from the U.S. Food and Drug Administration directing revisions to product labeling for its respiratory products Serevent® and Advair®.
2010-02-17	GlaxoSmithKline	Regulatory GSK statement on FDA’s proposed label revisions for some asthma medicines gsk.com ↗ GlaxoSmithKline is reviewing label changes proposed today by the US Food and Drug Administration (FDA) for asthma medications containing long-acting beta-agonists (LABAs), such as GSK’s Advair (salmeterol / fluticasone propionate).
2009-03-17	Teva Branded Pharmaceutical Products R&D, Inc.	Results Study Demonstrates that Qvar® is More Likely to Achieve Successful Asthma Control with Less Exacerbations tevapharm.com ↗ This real life analysis showed that the choice of ICS may impact overall asthma control under actual living conditions, including asthma exacerbation rates.

All press releases naming this drug 65 releases

Date	Issuer	Release
2026-08-20	Glenmark Pharmaceuticals Ltd. India	Glenmark Pharmaceuticals receives U.S. FDA approval for Fluticasone Propionate Nasal Spray, 0.05 mg (50 mcg)/spray glenmarkpharma.com ↗
2026-03-19	Glenmark Pharmaceuticals Ltd. India	Glenmark Therapeutics Inc., USA launches Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC) glenmarkpharma.com ↗
2026-03-04	Glenmark Pharmaceuticals Ltd. India	Glenmark Specialty SA Receives U.S. FDA Approval for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, with 180-Day Competitive Generic Therapy Exclusivity glenmarkpharma.com ↗
2025-03-19	Paratek Pharmaceuticals Inc	Paratek Pharmaceuticals to Acquire Optinose, Creating Significant Commercial Expansion Opportunities for XHANCE® in Chronic Rhinosinusitis (CRS) paratekpharma.com ↗
2024-04-18	Mundipharma Research Limited	Mundipharma and Vectura announce plans to reformulate flutiform® (fluticasone propionate/formoterol fumarate) pressurised metered- dose inhaler (pMDI) as a commitment to reducing the product’s carbon footprint mundipharma.com ↗
2021-11-30	NicOx Inc.	Nicox’s Positive Post Hoc Results from NCX 4251 Phase 2b Mississippi Trial Suggest Path Forward in Dry Eye Disease nicox.com ↗
2021-09-24	NicOx Inc.	Nicox Announces Results from the NCX 4251 Phase 2b Mississippi Blepharitis Trial nicox.com ↗
2021-06-01	Lannett Company, Inc.	Lannett Announces FDA Acceptance, As A Priority Original ANDA, Of The Generic Advair Diskus® Filing investorroom.com ↗
2021-04-01	Lannett Company, Inc.	Lannett Submits ANDA For Generic ADVAIR DISKUS® investorroom.com ↗
2021-01-26	Pharmascience Inc.	Pharmascience inc. lance pms-FLUTICASONE HFA 250mcg pour le traitement de l’asthme bronchique sensible aux corticostéroïdes chez les adultes et les enfants pharmascience.com ↗
2020-09-21	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Launches Two Digital Inhalers in the U.S., AirDuo® Digihaler® (fluticasone propionate and salmeterol) Inhalation Powder and ArmonAir® Digihaler® (fluticasone propionate) Inhalation Powder tevapharm.com ↗
2020-08-17	Lannett Company, Inc.	Lannett Signs Agreement To Be Exclusive Distributor Of Generic Flovent® Diskus® investorroom.com ↗
2020-06-05	Novartis Pharmaceuticals	Novartis Phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair® Breezhaler® (QVM149) versus a free combination of two existing inhaled treatments in uncontrolled asthma novartis.com ↗
2020-02-24	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces FDA Approval of ArmonAir® Digihaler™ (fluticasone propionate) Inhalation Powder tevapharm.com ↗
2019-07-15	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces FDA Approval of AirDuo® Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder tevapharm.com ↗
2019-03-12	Adare Pharmaceuticals, Inc.	Primary End-Point achieved in Phase IIb Study (FLUTE™) for APT-1011 adarepharmasolutions.com ↗
2018-09-10	Glenmark Pharmaceuticals Ltd. India	Glenmark secures marketing authorization in Germany for its generic version of Seretide® Accuhaler® glenmarkpharma.com ↗
2018-03-19	Orion Corporation, Orion Pharma	Orion has received positive conclusions for the salmeterol-fluticasone Easyhaler® combination under the EU's decentralized procedures orionpharma.com ↗
2017-11-27	Novartis Pharmaceuticals	Novartis' Ultibro® Breezhaler® significantly improved COPD patients' lung function after direct switch from Seretide® novartis.com ↗
2017-09-20	GlaxoSmithKline	GSK and Innoviva report positive headline results from IMPACT study showing single inhaler triple therapy Trelegy Ellipta reduced COPD exacerbations gsk.com ↗
2017-06-15	Novartis Pharmaceuticals	FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus® novartis.com ↗
2017-06-14	Sun Pharma Advanced Research Company Limited	SPARC Announces Top-line Results of Pivotal Peak Inspiratory Flow (PIF) study and Low Dose Pharmacokinetic (PK) Study for Salmeterol – Fluticasone Dry Powder Inhaler (SPARC DPI) SPARC DPI meets the end point for PIF study In the Low dose PK study bio-equivalence established for Fluticasone, however, Salmeterol component not bio equivalent to the comparator arm sparc.life ↗
2017-05-23	Novartis Pharmaceuticals	Novartis' new analyses reinforce the potential of Ultibro® Breezhaler® for COPD patients historically treated with steroids novartis.com ↗
2017-04-20	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Launches AirDuo™ RespiClick® and its Authorized Generic, Two Inhalers Containing Fluticasone Propionate and Salmeterol tevapharm.com ↗
2017-02-23	GlaxoSmithKline	Positive results for Relvar® Ellipta® lung function study in patients with well-controlled asthma gsk.com ↗
2017-01-30	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces FDA Approval of Two New RespiClick® Maintenance Inhalers for the Treatment of Asthma tevapharm.com ↗
2016-12-21	Orion Corporation, Orion Pharma	Orion is planning to apply for a marketing authorisation for combined salmeterol-fluticasone formulation of the Easyhaler® product family orionpharma.com ↗
2016-09-05	Nxera Pharma UK Limited	New findings confirm UltibroR BreezhalerR is consistently more effective than SeretideR in reducing COPD flare-ups across different patient groups nxera.life ↗
2016-09-03	Novartis Pharmaceuticals	Novartis' Ultibro® Breezhaler® consistently more effective than Seretide®* in reducing COPD flare-ups across different patient groups novartis.com ↗
2016-09-01	GlaxoSmithKline	NEJM publishes results of GSK’s long-term LABA safety study of Advair® Diskus® in children aged 4-11 years with asthma gsk.com ↗
2016-08-31	Novartis Pharmaceuticals	AirFluSal® Forspiro® showed superiority at 12 months over Seretide® Diskus®[1] in persistence to treatment novartis.com ↗
2016-06-28	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces FDA Acceptance of New Drug Applications for Fluticasone Propionate/Salmeterol and Fluticasone Propionate RespiClick® Inhalers tevapharm.com ↗
2016-05-31	Perrigo Company	Perrigo Announces FDA Approval And Launch Of The Store Brand Equivalent To Flonase® perrigo.com ↗
2016-05-16	Nxera Pharma UK Limited	Major study published in NEJM confirms Ultibro Breezhaler superiority over Seretide in preventing COPD exacerbations nxera.life ↗
2016-05-15	Novartis Pharmaceuticals	Major study published in NEJM confirms Novartis' Ultibro® Breezhaler® superiority over Seretide® in preventing COPD exacerbations novartis.com ↗
2016-03-17	GlaxoSmithKline	GSK’s Advair® Diskus® achieves primary endpoint in LABA safety study of children aged 4-11 years with asthma gsk.com ↗
2016-02-09	Boehringer Ingelheim	Newly Published Head-to-Head Data Show STIOLTO RESPIMAT Improved Lung Function Across Range of Measures prnewswire.com ↗
2015-11-24	Niox	Circassia Announces Positive Outcome of European Decentralised Procedure for Approval of Its Fluticasone Propionate Equivalent of GSK’s FLIXOTIDE® pMDI niox.com ↗
2015-11-19	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Reports Positive Top-Line Results from Phase III Trials Evaluating Fluticasone Propionate/Salmeterol and Fluticasone Propionate Multidose Dry Powder Inhalers (MDPIs) in Patients with Asthma tevapharm.com ↗
2015-11-17	Nxera Pharma UK Limited	FLAME Study Shows Superiority of Ultibro Breezhaler over Seretide in Reducing COPD Exacerbations nxera.life ↗
2015-10-27	GlaxoSmithKline	GSK’s Advair® Diskus® achieves primary endpoint in LABA safety study of patients with asthma gsk.com ↗
2015-09-28	Boehringer Ingelheim	New Head-to-Head STIOLTO RESPIMAT Data Presented at ERS Annual Congress prnewswire.com ↗
2015-05-19	GlaxoSmithKline	GSK presents data at ATS on the role of blood eosinophil levels as a potential biomarker in the treatment of COPD gsk.com ↗
2014-10-17	GlaxoSmithKline	Data published on Anoro® Ellipta® demonstrate improved lung function compared to tiotropium gsk.com ↗
2014-09-08	Boehringer Ingelheim	Boehringer Ingelheim Presents Pivotal Phase III Data for the Investigational Fixed-Dose Combination of Tiotropium + Olodaterol in COPD prnewswire.com ↗
2014-09-08	GlaxoSmithKline	GSK data presented at ERS demonstrate potential of blood eosinophil levels to help inform COPD treatment decisions gsk.com ↗
2014-09-08	Nxera Pharma UK Limited	Positive results from three clinical trials presented at ERS 2014 further confirmed efficacy of Ultibro Breezhaler and Seebri Breezhaler, and promotion agreement with Pfizer in the UK nxera.life ↗
2014-08-20	GlaxoSmithKline	GSK receives FDA approval for Arnuity™ Ellipta® (fluticasone furoate) in the USA for the treatment of asthma gsk.com ↗
2014-07-24	GlaxoSmithKline	FDA approves Flonase allergy relief for sale over-the-counter in the United States gsk.com ↗
2014-07-04	GlaxoSmithKline	Anoro® Ellipta® (umeclidinium/vilanterol) gains approval in Japan for the treatment of COPD gsk.com ↗
2014-06-30	GlaxoSmithKline	GSK and Theravance announce submission to US regulatory authorities for fluticasone furoate/vilanterol in asthma gsk.com ↗
2014-05-19	GlaxoSmithKline	GSK presents positive data at ATS 2014 from study evaluating efficacy and safety of Incruse™ Ellipta® added to Advair® Diskus® in patients with COPD gsk.com ↗
2014-04-30	Nxera Pharma UK Limited	Once-daily Ultibro Breezhaler showed superior efficacy versus Seretide for COPD patients in second head-to-head study, and the anticipated timing of China filing nxera.life ↗
2014-04-22	GlaxoSmithKline	GSK and Theravance announce phase III study of fluticasone furoate/vilanterol in COPD commenced to support potential future filing in Japan gsk.com ↗
2014-03-14	GlaxoSmithKline	GSK and Theravance announce positive results from studies comparing ANORO™ ELLIPTA™ with SERETIDE® DISKUS® and ADVAIR® DISKUS® in patients with COPD gsk.com ↗
2013-12-06	GlaxoSmithKline	GSK and Theravance announce positive results from pivotal phase III study for fluticasone furoate/vilanterol in asthma gsk.com ↗
2013-10-23	GlaxoSmithKline	GSK announces US regulatory submission for fluticasone furoate monotherapy for asthma gsk.com ↗
2013-07-31	Perrigo Company	Perrigo Announces FDA Final Approval For Generic Equivalent To Cutivate® Lotion, 0.05% perrigo.com ↗
2013-07-12	GlaxoSmithKline	Regulatory update: fluticasone furoate/vilanterol submission in Japan gsk.com ↗
2012-03-23	GlaxoSmithKline	GSK and Theravance announce completion of the Relovair™* registrational programme and topline results from Relovair™ vs. Advair® phase III studies in COPD gsk.com ↗
2011-05-10	Perrigo Company	Perrigo Announces Settlement of Cutivate Lotion Litigation perrigo.com ↗
2010-06-01	GlaxoSmithKline	GSK announces revised product labels for Serevent and Advair gsk.com ↗
2010-02-17	GlaxoSmithKline	GSK statement on FDA’s proposed label revisions for some asthma medicines gsk.com ↗
2009-03-17	Teva Branded Pharmaceutical Products R&D, Inc.	Study Demonstrates that Qvar® is More Likely to Achieve Successful Asthma Control with Less Exacerbations tevapharm.com ↗
2009-02-03	GlaxoSmithKline	GSK and Theravance announce positive phase 2b results for once-daily fluticasone furoate in the treatment of asthma gsk.com ↗

Evidence & citations 33 cited values

Every value below carries the sentence it was read from. 330 sources stand behind the page.

Field	Value	Cited text
Known as	Fluticasone propionate	“Fluticasone propionate nasal spray (Fushuliang) combined with Azlastine hydrochloride tablets (Kedumin), Fluticasone propionate nasal spray (Fushuliang) 1 spray (50 µ g...” NCT07294326 ↗ 313 “A Multicenter, Randomized, Double-blind, Parallel Group, 40-week Comparison of Asthma Control Using Bronchial Hyperresponsiveness as an Additional Guide to Long-term Treatment...” NCT00920543 ↗ “Fluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of two inhalations twice daily, to a maximum dose of 10 inhalations twice...” NCT00562159 ↗ “PURPOSE: Using sputum neutrophils as the primary measure, and other inflammation biomarkers, this study evaluated the anti-inflammatory effects of the combination salmeterol 50...” PMID 25945045 ↗ Apr 2015 “BACKGROUND: This study tested the clinical non-inferiority of the fluticasone propionate/salmeterol combination 50/250 μg (FSC) Rotacaps®/Rotahaler® system, a single unit dose...” PMID 28115223 ↗ Jan 2017 “OBJECTIVE: We sought to investigate the efficacy and safety of the oral CRTH2 antagonist BI 671800 (50, 200, and 400 mg twice daily), fluticasone propionate nasal spray (200 μg...” PMID 24332218 ↗ Dec 2013 “Umeclidinium (UMEC; long-acting muscarinic antagonist [LAMA])/vilanterol (VI; long-acting beta2-agonist [LABA]) and fluticasone propionate/salmeterol (FP/SAL) (inhaled...” PMID 26006754 ↗ May 2015 “The purpose of this study is to optimise the device and/or formulation of the Fluticasone propionate (FP)/salmeterol (SALM) unit dose powder inhaler (Rotahaler) to achieve drug...” NCT01540708 ↗ “We randomly assigned 285 participants two or three years of age with a positive asthma predictive index to treatment with fluticasone propionate (at a dose of 88 mug twice...” PMID 16687711 ↗ May 2006 “Each subject will receive SKP FlutiForm HFA pMDI 250/10 microgram twice daily for 60 weeks (two actuations of SKP FlutiForm HFA pMDI 125/5 microgram/actuation) for a total...” NCT00747318 ↗ “Fourteen subjects with moderate asthma inhaled single doses of salmeterol (50 μg), fluticasone propionate (250 μg), salmeterol/fluticasone propionate (50/250 μg), or placebo;...” PMID 21980058 ↗ Oct 2011 Show 303 more sources
Known as	Cutivate	“using Cutivate (fluticasone propionate, 0.05%)lotion” NCT00546000 ↗
Known as	EDS-FLU	“A new exhalational delivery system fluticasone spray (EDS-FLU) has been FDA-approved for patients with chronic rhinosinusitis with polyps.” NCT05275686 ↗
Known as	EP-104IAR	“A Randomized, Double-Blind, Placebo-Controlled, Phase I Trial Evaluating the Pharmacokinetics, Safety and Preliminary Efficacy of EP-104IAR (Long-Acting Fluticasone Propionate)...” NCT02609126 ↗
Known as	FF	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02924688 ↗
Known as	Flixonase	“Children whose parents had difficulty with CGMS due to irritation, redness were offered to use Flixonase (FLUTICASONE PROPIONATE), with an approval form 29ג, indicating it is...” NCT03594565 ↗ 2 “intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts each nostril once a day (i.e. total intranasal FP daily dose 200ug).” NCT00903227 ↗ “Fluticasone Propionate - FLIXONASE® brand” NCT04332978 ↗
Known as	Flixotide	“The clinical trial is to investigate the pharmacokinetic effects (that is how much drug is in the blood) of Fluticasone Propionate (Flixotide), a commonly used steroid drug...” NCT00692978 ↗ 11 “These patients will never have been prescribed the components present in Seretide (Salmeterol and Flixotide or similar compounds).” NCT00974805 ↗ “Flixotide® (fluticasone propionate) via accuhaler (Diskus) dry powder inhaler device” NCT00655616 ↗ “Fluticasone propionate (FLIXOTIDE™) at a dose of 200μg twice daily” NCT00353873 ↗ “FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)” NCT00453778 ↗ “100 mcg Flixotide (FP only) via Diskus inhaler” NCT00455923 ↗ “and/or Fluticasone Propionate (Flixotide®)” NCT00158834 ↗ NCT01511367 ↗ NCT01738087 ↗ NCT00456313 ↗ NCT00734318 ↗ Show 1 more source
Known as	Flixotide Evohaler	“Fluticasone Propionate (FP) Product name: Flixotide Evohaler® Manufacturer: Allan and Hanbury's Active ingredients: Fluticasone Propionate” NCT01388595 ↗ 2 “Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation)” NCT00830102 ↗ “Fluticasone propionate 125 micrograms (Trade name: Flixotide Evohaler)” NCT07582549 ↗
Known as	Flonase	“Xhance®, Flonase® (fluticasone propionate inhalational nasal spray), and Flovent® HFA (fluticasone propionate inhalational aerosol).” PMID 31732149 ↗ Nov 2019 4 “Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days” NCT02246920 ↗ “Nasal Steroid (Nasonex, Flonase)” NCT02874144 ↗ NCT02569437 ↗ NCT02748070 ↗
Known as	Flonase Allergy Relief	“This study is designed to visualize the response to use of fluticasone propionate nasal spray (Flonase Allergy Relief) to relieve facial allergy symptoms in individuals with...” NCT07817134 ↗ 1 “Flonase® Allergy Relief (fluticasone propionate) will be administered nasally (within 5 minutes of eyedrop) at Visits 3 and 4a.” NCT05314621 ↗
Known as	FLOVENT	“A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice...” NCT00452348 ↗ 4 “Fluticasone Propionate (FLOVENT) DISKUS 250 mcg BID” NCT00452699 ↗ “maintenance inhaled corticosteroid (Flovent)” NCT05689983 ↗ “FLOVENT (fluticasone propionate) HFA” NCT00370097 ↗ NCT00426283 ↗
Known as	Flovent Diskus	“Flovent Diskus contains the active ingredient fluticasone propionate (Fp). Flovent Diskus 100 mcg was used twice a day, once in the morning and evening, for a total daily dose...” NCT01479621 ↗ 2 “Flovent Diskus (fluticasone propionate multi-dose dry powder inhaler) 200 mcg twice daily for 12 weeks” NCT00071552 ↗ “Fluticasone propionate (Flovent Diskus) 250 mcg” NCT00716963 ↗
Known as	Flovent HFA	“Flovent® HFA (fluticasone propionate) inhalational aerosol” PMID 31732149 ↗ Nov 2019
Known as	fluticason propionate	“inhaled corticosteroid (fluticason propionate)” NCT00184977 ↗
Known as	fluticasone	“This study investigated the efficacy and tolerability of a new asthma therapy combining fluticasone propionate and formoterol fumarate (fluticasone/formoterol)*, administered...” PMID 23870606 ↗ Jul 2013 4 “combination spray of azelastine and fluticasone (antihistamine and steroid) compares with a steroid nasal spray (fluticasone) alone in allergic rhinitis” NCT00845598 ↗ “The authors did use fluticasone propionate and salmeterol (either the combination or fluticasone alone), which is marketed by GlaxoSmithKline.” PMID 23667615 ↗ May 2013 “in a 16-week observational inhaled fluticasone (FP) treatment study” NCT01554488 ↗ “Fluticasone is an inhaled corticosteroid” NCT02066129 ↗
Known as	Fluticasone Evohaler	“One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)” NCT00903227 ↗
Known as	Fluticasone Evohaler pMDI	“One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)” NCT00903227 ↗
Known as	Fluticasone propionate (generic name)	“Fluticasone propionate (generic name)” NCT02246920 ↗
Known as	Fluticasone propionate BP	“Azelastine Hydrochloride BP 0.10% w/v AND Fluticasone propionate BP 0.0357% w/v as combination” NCT00845598 ↗
Known as	fluticasone propionate nasal spray	“fluticasone propionate nasal spray” NCT00539006 ↗
Known as	Fluticasone Propionate Powder for Inhalation (Seretide)	“Fluticasone Propionate Powder for Inhalation (Seretide®)” NCT03169504 ↗
Known as	Fp MDPI	“Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir.” NCT01479621 ↗
Known as	FP500	“Evaluation of Novel Endpoints in Subjects with Chronic Obstructive Pulmonary Disease (COPD) in a Randomized, Double-Blind, Placebo-Controlled Study of Treatment with...” NCT00358358 ↗
Known as	FPANS	“Intranasal FPANS (Fluticasone Propionate aqueous nasal spray)” NCT00400998 ↗
Known as	FPNS	“OBJECTIVE: To compare fluticasone propionate nasal spray (FPNS) with the second-generation antihistamine cetirizine (oral tablet) and with placebo in a head-to-head study in a...” PMID 26108088 ↗ Jul 2015 1 NCT00519636 ↗
Known as	Fushuliang	“Fluticasone propionate nasal spray (Fushuliang) combined with Azlastine hydrochloride tablets (Kedumin), Fluticasone propionate nasal spray (Fushuliang) 1 spray (50 µ g...” NCT07294326 ↗
Known as	OPN-375	“OPN-375 (fluticasone propionate) delivered via exhalation delivery system (EDS) BID” NCT06850805 ↗
Known as	PF-00241939	“The purpose of this study is to investigate the time course of PF-00241939 concentration in the blood following dosing by oral inhalation from dry powder inhalers.” NCT00862667 ↗ 2 “PF-00241939 300 ug using inhaler A” NCT01181700 ↗ “PF-00241939 750ug using inhaler A” NCT00867282 ↗
Known as	PLURAIR	“Drug names: Fluticasone Propionate - PLURAIR® brand” NCT04332978 ↗
Known as	Xhance	“This study will compare placebo to fluticasone exhalational nasal spray system (Xhance) in a randomized, controlled study.” NCT05275686 ↗
Action	Activate	“This glucocorticoid is characterized by high lipophilicity, high glucocorticoid receptor binding and activation, and a rapid metabolic turnover in skin.” NCT03594565 ↗
Modality	Other / unclassified	“use of the inhaled corticosteroid” PMID 16687711 ↗ May 2006
Route	Inhaled	“Flovent Diskus (fluticasone propionate multi-dose dry powder inhaler)” NCT00071552 ↗