Fluticasone

also known as Fluticasone Propionate · OPN-375 · Flixotide · Flovent · Flixotide Evohaler · Flonase · Flovent [HFA] · Flu · +5 more

Other / unclassified

Developed for: asthma · chronic obstructive pulmonary disease · allergic rhinitis · allergic asthma · eosinophilic esophagitis · bronchiectasis · childhood onset asthma · chronic asthma
+18 more
· COVID-19 · allergic disease · atopic eczema · croup · cystic fibrosis · high altitude pulmonary edema · seasonal allergic rhinitis · transplant-related bronchiolitis obliterans · acute asthma · bacterial pneumonia · chronic rhinosinusitis · conjunctivitis · esophagitis · nasal cavity polyp · nicotine dependence · obstructive sleep apnea syndrome · psoriasis · viral pneumonia
Investigated by: GlaxoSmithKline · AstraZeneca · Mundipharma Research Limited · Boehringer Ingelheim · MEDA Pharma GmbH & Co. KG · Merck Sharp & Dohme LLC
+90 more
· National Heart, Lung, and Blood Institute (NHLBI) · Novartis Pharmaceuticals · University of British Columbia · Eurofarma Laboratorios S.A. · Far Eastern Memorial Hospital · National Center for Advancing Translational Sciences (NCATS) · Novartis · Susanna Naggie, MD · Taipei Veterans General Hospital, Taiwan · University of Virginia · Vanderbilt University Medical Center · Allergy & Asthma Medical Group & Research Center · Alpha Bioresearch S.L. · American Lung Association · Asan Medical Center · Assiut University · Associated Scientists to Help Minimize Allergies · Azienda Policlinico Umberto I · Benaroya Research Institute · Brian J Lipworth · British Lung Foundation · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Chiesi Farmaceutici S.p.A. · Children's Hospital Medical Center, Cincinnati · Claire Daniels · ClinResearch, GmbH · Cystic Fibrosis Trust · Dynamic Solutions · Egalet Ltd · Elena Rubio Gomis · Elpen Pharmaceutical Co. Inc. · European Research Council · FLUIDDA nv · Federico II University · Fundacion Investigación Hospital General Universitario de Valencia · Fundació d'investigació Sanitària de les Illes Balears · Gelb, Arthur F., M.D. · Hanmi Pharmaceutical Company Limited · Hospital Clinic of Barcelona · Hospital Infantil de Mexico Federico Gomez · Hospital Son Espases · Hospital Son Llatzer · Imperial College London · Inner-City Asthma Consortium · Instituto de Salud Carlos III · JHSPH Center for Clinical Trials · Maastricht University Medical Center · Mannkind Corporation · Mayo Clinic · McGill University Health Centre/Research Institute of the McGill University Health Centre · Medical Research Council of Canada · Milton S. Hershey Medical Center · Mundipharma Pharmaceuticals S.L. · National Institute of Allergy and Infectious Diseases (NIAID) · National Jewish Health · National Taiwan University Hospital · Nemours Children's Clinic · Neutec Ar-Ge San ve Tic A.Ş · Northwestern University · Organon and Co · Orion Corporation, Orion Pharma · Prolytic GmbH · Queen Mary University of London · Queen's University · Research Ethics Review Committee · Rhode Island Hospital · Royal Brompton & Harefield NHS Foundation Trust · Sandler Family Supporting Foundation · Sanofi · Seoul National University Hospital · Shanghai Pulmonary Hospital, Shanghai, China · Shin-hwar Wu · Sociedad Española de Neumología y Cirugía Torácica · Spanish Research Center for Respiratory Diseases · all 96 on the full record

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed asthma 5 milestones
Filed	US (FDA)	Advair Diskus	asthma	2021-06-01	“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” investorroom.com ↗
Filed	US (FDA)	—	asthma	2017-06-15	“FDA has accepted its Abbreviated New Drug Application for fluticasone propionate / salmeterol combination product, a substitutable generic version of Advair Diskus ®” novartis.com ↗
Filed	US (FDA)	RespiClick	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 ↗
Rejected (CRL)	US (FDA)	Advair Diskus	asthma	—	“Generic ADVAIR DISKUS®, fluticasone propionate and salmeterol inhalation powder, remains on priority review. The company anticipates fully responding to the CRL next year” investorroom.com ↗
Filed	EU (EMA)	—	asthma	—	“In April 2017 Orion submitted a marketing authorisation application for a salmeterol-fluticasone combined formulation in Europe, and the process is progressing according to the...” orionpharma.com ↗ “In April 2017 Orion submitted a marketing authorisation application for a salmeterol-fluticasone combined formulation in Europe.” orionpharma.com ↗
Filed chronic obstructive pulmonary disease 2 milestones
Filed	EU (EMA)	—	chronic obstructive pulmonary disease	2016-12-02	“today announced the filing by GSK of a regulatory submission with the European Medicines Agency for once-daily, closed triple combination therapy fluticasone...” gsk.com ↗
Filed	US (FDA)	—	chronic obstructive pulmonary disease	2016-11-21	“today announced the filing by GSK of a regulatory submission with the US Food and Drug Administration for the once-daily, closed triple combination therapy fluticasone...” gsk.com ↗

Trials 88 · started per year

today

20002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT05748977	Feb 2023 → Feb 2024	chronic obstructive pulmonary disease	Assiut University	Unknown	No outcome recorded
Phase 18 trials · 1 met primary
Phase 1	NCT03238482	Aug → Dec 2017	asthma	Orion Corporation, Orion Pharma	Completed	No outcome recorded
Phase 1	NCT02441114	Jul → Oct 2015	chronic obstructive pulmonary disease	Seoul National University Hospital	Completed	No outcome recorded
Phase 1	NCT02403713	Aug → Oct 2014	asthma	Mundipharma Research Limited	Completed	No outcome recorded
Phase 1	NCT01521455	Feb 2012 → Jun 2013	asthma	Hanmi Pharmaceutical Company Limited	Completed	No outcome recorded
Phase 1	NCT01190852	Aug → Oct 2010	allergic rhinitis	MEDA Pharma GmbH & Co. KG	Completed	No outcome recorded
Phase 1	NCT00674050	May → Sep 2008	diabetes mellitus	Mannkind Corporation	Completed	No outcome recorded
Phase 1	NCT00623714	Jan 2008 → Feb 2009	asthma	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 1	NCT01365650	Dec 2007 → Feb 2008	allergic rhinitis	Egalet Ltd	Completed	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT06040268	Dec 2023 → Dec 2026 expected	high altitude pulmonary edema	University of Colorado, Denver	Recruiting	No outcome recorded
Phase 210 trials · 3 met primary · 1 missed
Phase 2	NCT04179461	Mar 2018 → Oct 2019	childhood onset asthma	Children's Hospital Medical Center, Cincinnati	Completed	No outcome recorded
Phase 2	NCT03002389	Nov 2017 → Dec 2023 overdue	chronic obstructive pulmonary disease	University of Virginia	Active not recruiting	No outcome recorded
Phase 2	NCT02833480	Feb 2015 → Jan 2021	chronic obstructive pulmonary disease	University of British Columbia	Unknown	No outcome recorded
Phase 2	NCT01636076	Nov 2012 → Sep 2013	chronic obstructive pulmonary disease	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT00557440	Nov 2007 → Apr 2008	asthma	Novartis	Completed	Met primary
Phase 2	NCT00556673	Oct 2007 → Apr 2008	asthma	Novartis	Completed	Met primary
Phase 2	NCT00535366	Oct 2007 → Sep 2008	chronic obstructive pulmonary disease	Boehringer Ingelheim	Completed	No outcome recorded
Phase 2	NCT00387036	Dec 2006 → Jul 2009	chronic obstructive pulmonary disease	Merck Sharp & Dohme LLC	Terminated	Met primary Stop: Business
Phase 2	NCT00524095	Sep 2006 → Jul 2008	bronchiectasis, chronic bronchitis	University of Milan	Terminated	No outcome recorded
Phase 2	NCT00275561	Nov 2005 → Apr 2010	eosinophilic esophagitis	Mayo Clinic	Completed	Missed primary
Phase 2/32 trials
Phase 2/3	NCT02693769	Jul → Oct 2016	asthma	Mundipharma Research Limited	Terminated	No outcome recorded Stop: Enrollment
Phase 2/3	NCT02195375	Sep 2014 → May 2016	chronic obstructive pulmonary disease	Mundipharma Research Limited	Completed	No outcome recorded
Phase 314 trials · 1 met primary · 2 missed
Phase 3	NCT06234345	Jan 2027 → Aug 2028 expected	chronic obstructive pulmonary disease	Eurofarma Laboratorios S.A.	Not yet recruiting	No outcome recorded
Phase 3	NCT05735431	Jun 2026 → Nov 2027	chronic asthma	Eurofarma Laboratorios S.A.	Withdrawn	No outcome recorded Stop: Business
Phase 3	NCT05736874	Aug 2021 → Mar 2022	COVID-19	Susanna Naggie, MD	Completed	Missed primary
Phase 3	NCT04885530	Jun 2021 → Apr 2024	COVID-19	Susanna Naggie, MD	Completed	No outcome recorded
Phase 3	NCT03449836	Mar → Sep 2018	allergic disease	Federico II University	Completed	No outcome recorded
Phase 3	NCT03461627	Apr 2017 → Oct 2018	asthma	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Unknown	No outcome recorded
Phase 3	NCT01795664	Mar → Aug 2013	asthma	FLUIDDA nv	Completed	No outcome recorded
Phase 3	NCT01748162	Sep 2012 → Jun 2014	croup	University of Michigan	Terminated	No outcome recorded
Phase 3	NCT01772056	Dec 2009 → Jan 2012	atopic eczema	Elena Rubio Gomis	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT01484210	Mar → Aug 2008	asthma	Elpen Pharmaceutical Co. Inc.	Completed	No outcome recorded
Phase 3	NCT00476073	Apr 2007 → Jan 2008	asthma	Mundipharma Research Limited	Completed	Met primary
Phase 3	NCT00504062	Oct 2006 → Oct 2007	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00242775	May 2005 → May 2006	asthma	AstraZeneca	Completed	Missed primary
Phase 3	NCT00252863	Dec 2004 → May 2006	asthma	AstraZeneca	Completed	No outcome recorded

Phase 437 trials · 3 met primary · 2 missed
Phase 4	NCT07597473	May → Oct 2026 expected	allergic rhinitis	Viatris Inc.	Active not recruiting	No outcome recorded
Phase 4	NCT04503460	Jul 2021 → Sep 2024	asthma	Imperial College London	Unknown	No outcome recorded
Phase 4	NCT04652245	Dec 2020 → Dec 2021	seasonal allergic rhinitis	MEDA Pharma GmbH & Co. KG	Completed	Met primary
Phase 4	NCT04271839	Jun 2020 → May 2021	chronic asthma	Mundipharma Pharmaceuticals S.L.	Withdrawn	No outcome recorded
Phase 4	NCT03781596	Oct 2018 → Oct 2020	eosinophilic esophagitis	Claire Daniels	Unknown	No outcome recorded
Phase 4	NCT03363503	Apr 2018 → Apr 2022	chronic obstructive pulmonary disease	Neutec Ar-Ge San ve Tic A.Ş	Terminated	No outcome recorded
Phase 4	NCT02577497	Jun 2016 → Jul 2018	asthma	University of Virginia	Completed	No outcome recorded
Phase 4	NCT02238353	Oct 2014 → Dec 2015	allergic rhinitis, house allergic alveolitis	Universitaire Ziekenhuizen KU Leuven	Unknown	No outcome recorded
Phase 4	NCT02546349	Jul 2014 → Dec 2015	chronic obstructive pulmonary disease	Taipei Veterans General Hospital, Taiwan	Unknown	No outcome recorded
Phase 4	NCT02055352	May 2014 → Jan 2016	chronic obstructive pulmonary disease	Novartis Pharmaceuticals	Completed	Met primary
Phase 4	NCT02061280	Oct 2013 → Feb 2017	asthma	Nemours Children's Clinic	Completed	Mixed
Phase 4	NCT01741285	Apr 2013 → Jul 2015	asthma	University Medical Center Groningen	Completed	No outcome recorded
Phase 4	NCT01794780	Feb 2013 → May 2015	chronic obstructive pulmonary disease	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT01846962	Nov 2012 → Apr 2013	eosinophilic esophagitis	Azienda Policlinico Umberto I	Completed	No outcome recorded
Phase 4	NCT01520688	Feb 2012 → Feb 2016	asthma	West Penn Allegheny Health System	Completed	No outcome recorded
Phase 4	NCT01430403	Sep 2011 → Dec 2013	asthma	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Mixed
Phase 4	NCT02782312	Jun 2011 → Jun 2012	bronchiectasis	Shanghai Pulmonary Hospital, Shanghai, China	Completed	No outcome recorded
Phase 4	NCT01657487	Apr 2010 → Sep 2012	—	Far Eastern Memorial Hospital	Unknown	No outcome recorded
Phase 4	NCT01131806	Dec 2009 → Nov 2010	chronic obstructive pulmonary disease	Taipei Veterans General Hospital, Taiwan	Unknown	No outcome recorded
Phase 4	NCT01194700	Nov → Dec 2009	asthma	Brian J Lipworth	Completed	No outcome recorded
Phase 4	NCT00980707	Aug 2009 → Jun 2010	allergic asthma	Associated Scientists to Help Minimize Allergies	Completed	No outcome recorded
Phase 4	NCT00901368	May 2009 → Sep 2010	asthma	Chiesi Farmaceutici S.p.A.	Completed	No outcome recorded
Phase 4	NCT01225913	Oct 2007 → Jun 2027 expected	asthma	Gelb, Arthur F., M.D.	Recruiting	No outcome recorded
Phase 4	NCT00530842	Sep 2007 → Jan 2009	chronic obstructive pulmonary disease	Boehringer Ingelheim	Completed	Mixed
Phase 4	NCT00395239	Oct 2006 → Oct 2015	asthma	University of Alberta	Terminated	No outcome recorded
Phase 4	NCT00379028	Sep 2006 → Jul 2007	chronic obstructive pulmonary disease	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT00363480	May 2006 → Sep 2007	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00235053	Aug → Nov 2005	asthma, oral candidiasis, voice disorders	Allergy & Asthma Medical Group & Research Center	Completed	No outcome recorded
Phase 4	NCT00120978	Dec 2004 → Aug 2006	chronic obstructive pulmonary disease	University of British Columbia	Unknown	Missed primary
Phase 4	NCT02209974	Feb 2004 → Nov 2009	chronic obstructive pulmonary disease	Hospital Son Llatzer	Completed	No outcome recorded
Phase 4	NCT00239499	Sep 2003 → Aug 2004	chronic obstructive pulmonary disease	Boehringer Ingelheim	Completed	No outcome recorded
Phase 4	NCT00156819	Jun 2003 → Aug 2005	asthma	JHSPH Center for Clinical Trials	Completed	Missed primary
Phase 4	NCT00545324	Sep 2002 → Dec 2003	asthma	Organon and Co	Completed	No outcome recorded
Phase 4	NCT00175565	Jan 2002 → Jul 2003	chronic bronchitis, pulmonary emphysema	University of British Columbia	Completed	No outcome recorded
Phase 4	NCT00292838	Jan 2001 → Feb 2007	asthma, chronic obstructive pulmonary disease	St. Joseph's Healthcare Hamilton	Completed	No outcome recorded
Phase 4	NCT00440687	Jan 2001 → Mar 2004	chronic obstructive pulmonary disease	Queen Mary University of London	Completed	No outcome recorded
Phase 4	NCT00238927	Nov 1999 → Sep 2005	asthma	McGill University Health Centre/Research Institute of the McGill University Health Centre	Completed	Met primary

Phase not applicable15 trials
—	NCT02678949	Mar → Aug 2016	childhood onset asthma	Hospital Infantil de Mexico Federico Gomez	Unknown	No outcome recorded
—	NCT01933984	Aug 2013 → Jan 2019	chronic obstructive pulmonary disease	Shin-hwar Wu	Completed	No outcome recorded
—	NCT01537133	Oct 2012 → Jul 2014	asthma, atopic IgE-mediated allergic disorder	Milton S. Hershey Medical Center	Completed	No outcome recorded
—	NCT01881412	Aug 2012 → Dec 2017	asthma	Rhode Island Hospital	Terminated	No outcome recorded Stop: Business
—	NCT01327625	Mar 2011 → Jun 2013	graft versus host disease, transplant-related bronchiolitis obliterans	Asan Medical Center	Terminated	No outcome recorded
—	NCT00741767	Aug 2008 → Sep 2010	chronic obstructive pulmonary disease, sleep disorder	Northwestern University	Withdrawn	No outcome recorded Stop: Enrollment
—	NCT00559312	Dec 2007 → Mar 2010	chronic obstructive pulmonary disease	Queen's University	Completed	No outcome recorded
—	NCT00736801	Sep 2005 → Jan 2007	allergic asthma	University of Rostock	Completed	No outcome recorded
—	NCT00402207	Aug 2005 → Oct 2006	asthma	Maastricht University Medical Center	Completed	No outcome recorded
—	NCT00214019	Nov 2003 → Jan 2008	allergic asthma	University of Wisconsin, Madison	Completed	No outcome recorded
—	NCT00301171	Sep 2003 → Aug 2007	asthma	National Heart, Lung, and Blood Institute (NHLBI)	Completed	No outcome recorded
—	NCT00233051	Apr 2003 → Jun 2006	chronic bronchitis, pulmonary emphysema	National Jewish Health	Terminated	No outcome recorded
—	NCT00187499	Oct 2002 → Feb 2005	asthma	University of California, San Francisco	Completed	No outcome recorded
—	NCT00220259	May 2001 → Feb 2005	cystic fibrosis	Royal Brompton & Harefield NHS Foundation Trust	Completed	No outcome recorded
—	NCT00409630	—	asthma	University of Kansas	Withdrawn	No outcome recorded

Comparator or background therapy97 trials
Phase 1	NCT02162485 Comparator	Jun 2014 → Sep 2015	asthma	Orion Corporation, Orion Pharma	Completed	No outcome recorded
Phase 1	NCT01194622 Comparator	Aug → Oct 2010	allergic rhinitis	MEDA Pharma GmbH & Co. KG	Completed	No outcome recorded
Phase 1	NCT00908362 Comparator	May → Oct 2009	chronic obstructive pulmonary disease	University of Rostock	Completed	No outcome recorded
Phase 1	NCT00116402 Comparator	Jan 2005 → Sep 2009	chronic obstructive pulmonary disease	University of Chicago	Completed	No outcome recorded
Phase 2	NCT06705387 Comparator	Dec 2024 → Sep 2026 overdue	eosinophilic esophagitis	University of Colorado, Denver	Recruiting	No outcome recorded
Phase 2	NCT06676319 Background	Nov 2024 → Jun 2027 expected	asthma	Sanofi	Active not recruiting	No outcome recorded
Phase 2	NCT05922761 Background	May 2024 → Jun 2027 expected	chronic graft versus host disease, transplant-related bronchiolitis obliterans	Dana-Farber Cancer Institute	Recruiting	No outcome recorded
Phase 2	NCT03387852 Background	Mar 2018 → Mar 2019	asthma	Sanofi	Completed	Mixed
Phase 2	NCT03063086 Comparator	Jan 2017 → Aug 2018	asthma	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT02885025 Comparator	Oct 2016 → Mar 2019	allergic rhinitis	VA Office of Research and Development	Completed	No outcome recorded
Phase 2	NCT02063139 Comparator	Feb → Jun 2014	asthma	Mundipharma Research Limited	Completed	No outcome recorded
Phase 2	NCT03444506 Comparator	Jan → Feb 2014	seasonal allergic rhinitis	Glenmark Pharmaceuticals Ltd. India	Completed	Met primary
Phase 2	NCT01836471 Comparator	May 2013 → Feb 2016	asthma	Novartis Pharmaceuticals	Completed	Missed primary
Phase 2	NCT01312961 Background	Mar 2011 → Oct 2012	asthma	Sanofi	Completed	Met primary
Phase 2	NCT01209715 Comparator	Oct 2010 → May 2012	chronic obstructive pulmonary disease	University of Miami	Withdrawn	No outcome recorded
Phase 2	NCT01134328 Comparator	May → Jul 2010	conjunctivitis	Aciex Therapeutics, Inc.	Completed	No outcome recorded
Phase 2	NCT01070524 Comparator	Jan → Jul 2010	asthma	Chiesi Farmaceutici S.p.A.	Completed	No outcome recorded
Phase 2	NCT00929968 Comparator	Jun 2009 → Feb 2011	allergic rhinitis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT00695604 Comparator	May 2008 → Sep 2011	asthma	University of Chicago	Withdrawn	No outcome recorded
Phase 2	NCT00543686 Comparator	Aug 2007 → Jan 2009	childhood onset asthma	Johann Wolfgang Goethe University Hospital	Completed	No outcome recorded
Phase 2	NCT00123656 Comparator	Aug 2004 → Dec 2006	esophagitis	University of Utah	Completed	No outcome recorded
Phase 3	NCT04208581 Background	Oct 2019 → Dec 2021	chronic obstructive pulmonary disease, respiratory failure	Peking University People's Hospital	Unknown	Mixed
Phase 3	NCT03960580 Comparator	Jun 2019 → May 2022	chronic rhinosinusitis	Optinose US Inc.	Completed	No outcome recorded
Phase 3	NCT03747458 Comparator	Dec 2018 → Mar 2026	nasal cavity polyp	Optinose US Inc.	Completed	No outcome recorded
Phase 3	NCT03781804 Comparator	Nov 2018 → Jan 2022	chronic rhinosinusitis	Optinose US Inc.	Completed	No outcome recorded
Phase 3	NCT03158311 Comparator	Feb 2018 → Jul 2019	asthma	Novartis Pharmaceuticals	Completed	Met primary
Phase 3	NCT03387241 Comparator	Jun 2017 → Dec 2019	asthma	Mundipharma (China) Pharmaceutical Co. Ltd	Unknown	No outcome recorded
Phase 3	NCT03317015 Comparator	Nov 2016 → Jul 2017	allergic rhinitis	Sanofi	Completed	No outcome recorded
Phase 3	NCT02924688 Background	Oct 2016 → Feb 2019	asthma	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT02753712 Comparator	Jun 2016 → Aug 2017	asthma	Mundipharma Research Limited	Completed	No outcome recorded
Phase 3	NCT02665806 Comparator	Jan → Feb 2016	chronic rhinosinusitis	Tehran University of Medical Sciences	Unknown	No outcome recorded
Phase 3	NCT02477397 Comparator	May 2015 → Jun 2019	chronic obstructive pulmonary disease	University Medical Center Groningen	Unknown	No outcome recorded
Phase 3	NCT02270424 Background	Oct 2014 → Dec 2016	chronic obstructive pulmonary disease	Henan University of Traditional Chinese Medicine	Unknown	No outcome recorded
Phase 3	NCT02180672 Comparator	Sep 2014 → Dec 2019	obstructive sleep apnea syndrome	Children's Hospital of Philadelphia	Completed	No outcome recorded
Phase 3	NCT01834885 Comparator	Dec 2013 → Sep 2014	chronic obstructive pulmonary disease	Novartis Pharmaceuticals	Withdrawn	No outcome recorded
Phase 3	NCT01860066 Comparator	Dec 2013 → Sep 2014	chronic obstructive pulmonary disease	Novartis Pharmaceuticals	Withdrawn	No outcome recorded
Phase 3	NCT01915823 Comparator	Jul 2013 → Feb 2014	seasonal allergic rhinitis	Meda Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT01782326 Comparator	Jul 2013 → Sep 2015	chronic obstructive pulmonary disease	Novartis Pharmaceuticals	Completed	Met primary
Phase 3	NCT01868113 Comparator	Dec 2012 → Jan 2014	acute asthma, bacterial pneumonia, viral pneumonia	Makerere University	Completed	No outcome recorded
Phase 3	NCT01709903 Comparator	Nov 2012 → Feb 2014	chronic obstructive pulmonary disease	Novartis Pharmaceuticals	Completed	Met primary
Phase 3	NCT01570478 Comparator	Jul 2012 → Feb 2014	asthma	Chiesi Farmaceutici S.p.A.	Completed	No outcome recorded
Phase 3	NCT01511367 Comparator	Mar 2012 → Sep 2013	asthma	Mundipharma Research Limited	Completed	No outcome recorded
Phase 3	NCT01202084 Comparator	Jan → Nov 2012	asthma	Eurofarma Laboratorios S.A.	Completed	No outcome recorded
Phase 3	NCT01702701 Comparator	Jan 2012 → Jul 2017	eosinophilic esophagitis	Medical College of Wisconsin	Withdrawn	No outcome recorded
Phase 3	NCT01393145 Background	Aug 2011 → Aug 2012	chronic obstructive pulmonary disease	Ache Laboratorios Farmaceuticos S.A.	Withdrawn	No outcome recorded
Phase 3	NCT01245569 Comparator	Apr 2011 → Mar 2012	chronic obstructive pulmonary disease	Chiesi Farmaceutici S.p.A.	Completed	Met primary
Phase 3	NCT01315249 Comparator	Mar 2011 → Mar 2012	chronic obstructive pulmonary disease	Novartis Pharmaceuticals	Completed	Met primary
Phase 3	NCT00550550 Background	Nov 2007 → Sep 2009	allergic rhinitis, conjunctivitis	ALK-Abelló A/S	Completed	Met primary
Phase 3	NCT00563056 Comparator	Sep 2007 → Apr 2008	asthma	Mundipharma Research Limited	Completed	Met primary
Phase 3	NCT00497237 Comparator	Apr 2007 → Mar 2010	asthma	Chiesi Farmaceutici S.p.A.	Completed	Met primary
Phase 3	NCT00306163 Comparator	May 2006 → Aug 2008	asthma	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00127166 Background	Dec 2005 → Nov 2008	exercise-induced bronchoconstriction	Organon and Co	Completed	Met primary
Phase 3	NCT00314574 Background	Dec 2005 → Nov 2009	asthma	Genentech, Inc.	Completed	No outcome recorded
Phase 3	NCT00079937 Background	Apr 2004 → Mar 2008	asthma	Novartis Pharmaceuticals	Completed	Met primary
Phase 4	NCT07052942 Comparator	Aug 2025 → Nov 2029 expected	acute asthma	DARTNet Institute	Recruiting	No outcome recorded
Phase 4	NCT06572228 Background	Aug 2024 → Apr 2027 expected	asthma	Regeneron Pharmaceuticals	Active not recruiting	No outcome recorded
Phase 4	NCT06272370 Comparator	Feb → Sep 2024	asthma, hypersensitivity reaction disease, obstructive lung disease, respiratory tract infectious disorder	DARTNet Institute	Completed	No outcome recorded
Phase 4	NCT04671355 Comparator	Oct → Dec 2021	chronic obstructive pulmonary disease	Chiesi Farmaceutici S.p.A.	Withdrawn	No outcome recorded
Phase 4	NCT03395002 Comparator	Mar 2018 → Apr 2020	chronic obstructive pulmonary disease	Neutec Ar-Ge San ve Tic A.Ş	Completed	No outcome recorded
Phase 4	NCT02953106 Comparator	Jan 2017 → Sep 2018	allergic asthma, allergic rhinitis	University of Dundee	Terminated	No outcome recorded
Phase 4	NCT03004131 Comparator	Jan → Mar 2017	seasonal allergic rhinitis	MEDA Pharma GmbH & Co. KG	Completed	No outcome recorded
Phase 4	NCT02516592 Comparator	Oct 2015 → May 2017	chronic obstructive pulmonary disease	Novartis Pharmaceuticals	Completed	Met primary
Phase 4	NCT02019758 Comparator	Jan 2015 → May 2018	eosinophilic esophagitis	University of North Carolina, Chapel Hill	Completed	No outcome recorded
Phase 4	NCT01907334 Comparator	Aug 2013 → May 2014	asthma	University of Florida	Completed	No outcome recorded
Phase 4	NCT01696214 Comparator	Oct 2012 → May 2015	asthma	University of California, San Diego	Completed	No outcome recorded
Phase 4	NCT01437995 Comparator	Mar 2012 → Sep 2015	asthma	Johns Hopkins University	Completed	No outcome recorded
Phase 4	NCT00830505 Comparator	Apr 2009 → May 2010	asthma	University of Dundee	Completed	Met primary
Phase 4	NCT00845195 Background	Mar → May 2009	seasonal allergic rhinitis	Alcon Research	Completed	No outcome recorded
Phase 4	NCT00705341 Comparator	Jan 2009 → Feb 2010	asthma	Johns Hopkins Bloomberg School of Public Health	Completed	No outcome recorded
Phase 4	NCT00829257 Comparator	Jan 2009 → Jul 2010	asthma	University of Dundee	Completed	No outcome recorded
Phase 4	NCT00731770 Comparator	Jan 2009 → Apr 2010	chronic obstructive pulmonary disease	Milton S. Hershey Medical Center	Completed	No outcome recorded
Phase 4	NCT00655109 Comparator	Feb → Mar 2008	conjunctivitis	Greiner, Jack V., OD DO PhD	Completed	No outcome recorded
Phase 4	NCT00527826 Comparator	Nov 2007 → Jul 2009	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT01186653 Comparator	Oct 2007 → May 2010	chronic obstructive pulmonary disease	Hull University Teaching Hospitals NHS Trust	Completed	No outcome recorded
Phase 4	NCT01255579 Comparator	Jul 2007 → Dec 2008	asthma	University of Brescia	Completed	No outcome recorded
Phase 4	NCT00817050 Comparator	Dec 2004 → Jan 2005	allergic rhinitis	Organon and Co	Completed	No outcome recorded
Phase 4	NCT00783458 Comparator	Dec 2004 → Jan 2005	allergic rhinitis	Organon and Co	Completed	No outcome recorded
Phase 4	NCT00119158 Comparator	Oct 2004 → Jun 2005	atopic eczema	Children's Hospital of Philadelphia	Completed	No outcome recorded
Phase 4	NCT00690105 Comparator	Feb 2004 → Jul 2005	atopic eczema	Astellas Pharma Inc	Completed	No outcome recorded
Phase 4	NCT00689832 Comparator	Feb 2004 → Aug 2005	atopic eczema	Astellas Pharma Inc	Completed	No outcome recorded
Phase 4	NCT00763529 Comparator	Jan 2003 → Jan 2005	psoriasis	Organon and Co	Completed	No outcome recorded
Phase 4	NCT00606242 Comparator	Jan 2000 → Dec 2002	asthma	University of California, San Francisco	Completed	No outcome recorded
—	NCT07058259 Background	Nov 2024 → Jun 2025 overdue	chronic obstructive pulmonary disease	Istanbul Medeniyet University	Active not recruiting	No outcome recorded
—	NCT05706636 Comparator	Feb 2023 → Dec 2024	vitiligo	Cairo University	Completed	No outcome recorded
—	NCT04706559 Background	Jan → Sep 2021	atopic eczema	B.P. Koirala Institute of Health Sciences	Completed	No outcome recorded
—	NCT02790047 Background	Oct 2016 → Jan 2018	chronic obstructive pulmonary disease	Khon Kaen University	Unknown	No outcome recorded
—	NCT02415179 Comparator	May 2015 → Feb 2016	asthma	Mahidol University	Completed	No outcome recorded
—	NCT02194062 Comparator	Jan → Jul 2015	chronic rhinosinusitis, nasal cavity polyp	Yale University	Completed	No outcome recorded
—	NCT02556073 Background	Aug 2014 → Aug 2016	asthma	Taipei Veterans General Hospital, Taiwan	Unknown	No outcome recorded
—	NCT01240889 Comparator	Nov 2010 → Jul 2011	allergic disease	Creighton University	Completed	No outcome recorded
—	NCT01216735 Comparator	Sep 2008 → Dec 2009	nicotine dependence	University of Miami	Completed	No outcome recorded
—	NCT00880906 Comparator	Aug 2008 → Dec 2013	eosinophilic esophagitis	Vanderbilt University	Completed	No outcome recorded
—	NCT00895817 Comparator	Apr 2008 → Oct 2010	eosinophilic esophagitis	Walter Reed Army Medical Center	Completed	No outcome recorded
—	NCT00509197 Comparator	Oct 2007 → May 2010	asthma	University of Montreal	Terminated	No outcome recorded Stop: Enrollment
—	NCT00513487 Background	Jul → Nov 2007	allergic rhinitis	Novartis	Completed	No outcome recorded
—	NCT00521222 Comparator	Jun 2007 → Nov 2010	asthma	Columbia University	Completed	No outcome recorded
—	NCT02318043 Comparator	Jan → Dec 2007	asthma	Guangzhou Institute of Respiratory Disease	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 48

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.
2026-01-23	GlaxoSmithKline	Regulatory Trelegy Ellipta approved in China for use in adults with uncontrolled asthma gsk.com ↗ The approval means that FF/UMEC/VI is the first and only single inhaler triple therapy (SITT) approved for the maintenance treatment of both respiratory conditions in the country.
2021-09-03	Novartis Pharmaceuticals	Results Novartis presents new findings at ERS reinforcing the efficacy of Enerzair® Breezhaler®, highlighting its digital companion, as well as showcasing commitment to low carbon footprint asthma solutions novartis.com ↗
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 ↗
2018-05-21	GlaxoSmithKline	Regulatory GSK receives US approval of Arnuity Ellipta for use in children from 5 years old who suffer from asthma gsk.com ↗ The approval is for the use of Arnuity Ellipta as maintenance treatment of asthma as prophylactic therapy in children aged 5 to 11 years, delivered as a 50mcg once-daily dose using the Ellipta inhaler.
2018-03-19	Orion Corporation, Orion Pharma	Regulatory Orion has received positive conclusions for the salmeterol-fluticasone Easyhaler® combination under the EU's decentralized procedures orionpharma.com ↗ Orion Corporation has received positive conclusions for the salmeterol-fluticasone Easyhaler® combination under the EU's decentralized procedures (DCP).
2018-01-26	GlaxoSmithKline	Regulatory GSK announces CHMP positive opinion for labelling update to Relvar Ellipta in patients with asthma gsk.com ↗ We are very excited about achieving this CHMP positive opinion which, if approved, provides an additional option for physicians, who can prescribe once-daily Relvar Ellipta for their asthma patients
2017-12-21	GlaxoSmithKline	Regulatory FDA approves US label update on ICS/LABA combinations in asthma, based on review of safety data gsk.com ↗ These labelling updates were approved on December 20th 2017, after a review of safety data from 4 randomized controlled safety trials submitted by three companies, including GSK.
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].
2017-04-26	Orion Corporation, Orion Pharma	Regulatory Orion Group Interim Report January-March 2017 orionpharma.com ↗ After the review period, in April we submitted a marketing authorisation application for the new salmeterol-fluticasone combined formulation in the Easyhaler product family in Europe.
2017-02-23	GlaxoSmithKline	Results Positive results for Relvar® Ellipta® lung function study in patients with well-controlled asthma gsk.com ↗ In this positive study we have demonstrated non-inferiority for once-daily Relvar versus twice-daily Seretide on lung function.
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 ↗
2016-12-21	Orion Corporation, Orion Pharma	Results Orion is planning to apply for a marketing authorisation for combined salmeterol-fluticasone formulation of the Easyhaler® product family orionpharma.com ↗ Orion Corporation, a Finnish pharmaceutical and diagnostics company, has received favorable pharmacokinetic study results with combined salmeterol-fluticasone formulation of the Easyhaler® product family.
2016-12-02	GlaxoSmithKline	Regulatory Relvar® Ellipta® 100/25 mcg gains approval in Japan for use in patients with COPD gsk.com ↗ today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Relvar® Ellipta® (fluticasone furoate / vilanterol 100/25 mcg) for the relief of various symptoms with chronic obstructive pulmonary disease (chronic bronchitis, pulmonary emphysema) (in the case where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required).
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).
2016-06-28	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 ↗
2016-05-24	GlaxoSmithKline	Results Salford Lung Study results show COPD patients treated with Relvar® Ellipta® achieve superior reduction in exacerbations compared with ‘usual care’ gsk.com ↗ The study showed that Relvar® Ellipta® 100/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) achieved a superior reduction in exacerbations versus usual care, in patients with COPD, in an everyday clinical practice setting.
2016-05-16	Nxera Pharma UK Limited	Results Other nxera.life ↗
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 ↗ 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.
2016-05-15	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.
2016-03-06	GlaxoSmithKline	Results NEJM publishes results of GSK’s long-term LABA safety study of Advair ® Diskus® in adults and adolescents with asthma gsk.com ↗ This was assessed by the composite endpoint of serious asthma-related events (deaths, intubations or hospitalisations) and showed that Advair had a safety profile comparable to FP, including no asthma-related deaths in either arm.
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 ↗ There were a total of 67 patients with serious asthma-related events across the study with 34 patients with events on FSC treatment and 33 patients with events on FP treatment.
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.
2015-04-30	GlaxoSmithKline	Regulatory FDA approves BREO® ELLIPTA® for the treatment of adults with asthma in the US gsk.com ↗ Two strengths, 100/25mcg and 200/25mcg, have been approved in the US for use in asthma, administered once-daily using the Ellipta dry powder inhaler.
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.
2014-07-24	GlaxoSmithKline	Regulatory FDA approves Flonase allergy relief for sale over-the-counter in the United States 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 ↗
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 ↗ We are pleased to announce the results from these positive studies, which provide physicians with further data regarding UMEC/VI as a treatment option for appropriate patients with COPD.
2013-09-20	GlaxoSmithKline	Regulatory RELVAR™ ELLIPTA™ gains approval in Japan for the treatment of asthma gsk.com ↗ today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved RELVAR™ ELLIPTA™ for the treatment of bronchial asthma (in cases where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required).
2013-07-01	Elpen Pharmaceutical Co. Inc.	Regulatory ELPEN PHARMA GmbH: «Δυναμική απόβαση» της ELPEN στη Γερμανία! elpen.gr ↗ H ελληνική φαρμακευτική βιομηχανία ELPEN έγινε η πρώτη φαρμακοβιομηχανία ΠΑΓΚΟΣΜΙΩΣ που έλαβε έγκριση για την κυκλοφορία στην Ευρώπη του συνδυασμού των φαρμακευτικών ουσιών φλουτικαζόνης και σαλμετερόλης (Fluticasone + Salmeterol):
2013-05-10	GlaxoSmithKline	Regulatory BREO™ ELLIPTA™ gains US approval for the treatment of COPD gsk.com ↗ GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved BREO™ ELLIPTA™ as an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
2013-04-17	GlaxoSmithKline	Regulatory FDA Advisory Committee recommends approval of BREO(TM) ELLIPTA(TM) for the treatment of COPD gsk.com ↗ This positive recommendation is a crucial first step towards making BREO ELLIPTA available for appropriate COPD patients across the US.
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.
2012-01-09	GlaxoSmithKline	Results GSK and Theravance announce initial outcomes from pivotal Phase III studies for once-daily Relovair™* in COPD and asthma gsk.com ↗ There was no statistical difference between FF/VI and FP/SAL.
2011-10-18	Elpen Pharmaceutical Co. Inc.	Regulatory 18.10.2011 Παγκόσμια Αναγνώριση για την ELPEN elpen.gr ↗ Παράλληλα έχει ήδη εγκριθεί με εθνική διαδικασία έγκρισης φαρμάκων σε Ελλάδα, Κύπρο και Μάλτα, όπου κυκλοφορεί.
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.
2009-02-03	GlaxoSmithKline	Results GSK and Theravance announce positive phase 2b results for once-daily fluticasone furoate in the treatment of asthma gsk.com ↗

All press releases naming this drug 59 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 ↗
2026-01-23	GlaxoSmithKline	Trelegy Ellipta approved in China for use in adults with uncontrolled asthma gsk.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 ↗
2021-09-03	Novartis Pharmaceuticals	Novartis presents new findings at ERS reinforcing the efficacy of Enerzair® Breezhaler®, highlighting its digital companion, as well as showcasing commitment to low carbon footprint asthma solutions novartis.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 ↗
2018-05-21	GlaxoSmithKline	GSK receives US approval of Arnuity Ellipta for use in children from 5 years old who suffer from asthma gsk.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 ↗
2018-01-26	GlaxoSmithKline	GSK announces CHMP positive opinion for labelling update to Relvar Ellipta in patients with asthma gsk.com ↗
2017-12-21	GlaxoSmithKline	FDA approves US label update on ICS/LABA combinations in asthma, based on review of safety data gsk.com ↗
2017-11-27	Novartis Pharmaceuticals	Novartis' Ultibro® Breezhaler® significantly improved COPD patients' lung function after direct switch from Seretide® novartis.com ↗
2017-04-26	Orion Corporation, Orion Pharma	Orion Group Interim Report January-March 2017 orionpharma.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 ↗
2016-12-02	GlaxoSmithKline	Relvar® Ellipta® 100/25 mcg gains approval in Japan for use in patients with COPD gsk.com ↗
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 ↗
2016-06-28	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 ↗
2016-05-24	GlaxoSmithKline	Salford Lung Study results show COPD patients treated with Relvar® Ellipta® achieve superior reduction in exacerbations compared with ‘usual care’ gsk.com ↗
2016-05-16	Nxera Pharma UK Limited	Other nxera.life ↗
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 ↗
2016-03-06	GlaxoSmithKline	NEJM publishes results of GSK’s long-term LABA safety study of Advair ® Diskus® in adults and adolescents with asthma gsk.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 ↗
2015-05-19	GlaxoSmithKline	GSK presents data at ATS on the role of blood eosinophil levels as a potential biomarker in the treatment of COPD gsk.com ↗
2015-04-30	GlaxoSmithKline	FDA approves BREO® ELLIPTA® for the treatment of adults with asthma in the US 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 ↗
2014-08-20	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 ↗
2014-06-30	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 ↗
2013-09-20	GlaxoSmithKline	RELVAR™ ELLIPTA™ gains approval in Japan for the treatment of asthma gsk.com ↗
2013-07-12	GlaxoSmithKline	Regulatory update: fluticasone furoate/vilanterol submission in Japan gsk.com ↗
2013-07-01	Elpen Pharmaceutical Co. Inc.	ELPEN PHARMA GmbH: «Δυναμική απόβαση» της ELPEN στη Γερμανία! elpen.gr ↗
2013-05-10	GlaxoSmithKline	BREO™ ELLIPTA™ gains US approval for the treatment of COPD gsk.com ↗
2013-04-17	GlaxoSmithKline	FDA Advisory Committee recommends approval of BREO(TM) ELLIPTA(TM) for the treatment of COPD 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 ↗
2012-01-09	GlaxoSmithKline	GSK and Theravance announce initial outcomes from pivotal Phase III studies for once-daily Relovair™* in COPD and asthma gsk.com ↗
2011-10-18	Elpen Pharmaceutical Co. Inc.	18.10.2011 Παγκόσμια Αναγνώριση για την ELPEN elpen.gr ↗
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 16 cited values

Every value below carries the sentence it was read from. 189 sources stand behind the page.

Field	Value	Cited text
Known as	Fluticasone	“participants will use either a combination of budesonide/formoterol or mometasone/formoterol as both controller and rescue therapy or a stand alone inhaled steroid...” NCT06272370 ↗ 180 “This pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone, salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250...” NCT02441114 ↗ “Study to Assess the Absorption and Tolerability of Intranasal Ketorolac Tromethamine and to Assess the Effects of Oxymetazoline Hydrochloride and Fluticasone Propionate on the...” NCT01365650 ↗ “A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Cetirizine 0.1%/Fluticasone 0.005% Ophthalmic Solution Compared to Its Components and Vehicle in a...” NCT01134328 ↗ “Topical corticosteroid (i.e. Fluticasone 0.05% cream) and topical calcineurin inhibitor (tacrolimus 0.1% ointment) for sensitive areas like periorbital regions, flexures and...” NCT04706559 ↗ “Each patient will routinely receive 4 puffs of 25 mcg salmeterol /250 mcg fluticasone (Seretide Evohaler 250; GlaxoSmithKline Inc. Evreux, France) every 12 hours until the...” NCT01933984 ↗ “The study evaluated the efficacy of beclomethasone dipropionate/formoterol fumarate (BDP/FF) extrafine combination versus fluticasone propionate/salmeterol (FP/S) combination...” PMID 24621109 ↗ Mar 2014 “Triple Therapy (LABA + LAMA + ICS): Patients receive the above combination of LABA and LAMA plus an inhaled corticosteroid (ICS) such as Budesonide, Fluticasone, or Beclometasone.” NCT07058259 ↗ “Seretide® Accuhaler® (fluticasone propionate 250 μg plus salmeterol xinafoate 50 μg per actuation), 1 inhalation b.i.d. (daily dose of fluticasone 500 μg plus salmeterol 100 μg)” NCT01570478 ↗ “The potent inhaled corticosteroid, fluticasone propionate (fluticasone), and the long-acting β2-agonist with a rapid onset of action, formoterol fumarate (formoterol)” PMID 23368897 ↗ Feb 2013 “There have been studies noting that swallowed fluticasone propionate (FP), an inhaled corticosteroid, has shown benefit in adult and pediatric patients with EE.” NCT00880906 ↗ Show 170 more sources
Known as	Flixotide	“fluticasone plus formoterol (Flixotide Evohaler, pMDI, Flovent [HFA]; Foradil, DPI, Foradil Aerolizer) administered concurrently” PMID 23368897 ↗ Feb 2013 1 “fluticasone (Flixotide, 250 µg b.i.d.)” NCT00239499 ↗
Known as	Flixotide Evohaler	“fluticasone plus formoterol (Flixotide Evohaler, pMDI, Flovent [HFA]; Foradil, DPI, Foradil Aerolizer) administered concurrently” PMID 23368897 ↗ Feb 2013
Known as	Flonase	“fluticasone propionate nasal spray (Flonase) plus loratadine 10 mg tablets (Claritin)” NCT03004131 ↗
Known as	Flovent	“inhaled fluticasone (Flovent®) reduces systemic inflammation” NCT00120978 ↗ 1 “fluticasone (also known as Flovent)” NCT06705387 ↗
Known as	Flovent [HFA]	“fluticasone plus formoterol (Flixotide Evohaler, pMDI, Flovent [HFA]; Foradil, DPI, Foradil Aerolizer) administered concurrently” PMID 23368897 ↗ Feb 2013
Known as	Flu	“The participants were then randomized to budesonide/formoterol (Bud + Form; 400/12 μg BID), fluticasone/salmeterol (Flu + Salm; 250/50 μg BID), or formoterol only (12 μg BID)...” PMID 34464242 ↗ Nov 2021
Known as	fluticasone Diskus	“To compare the efficacy of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks to that of fluticasone Diskus® 50 μg/dose and 100 μg/dose twice daily for 6 week.” NCT00504062 ↗
Known as	Fluticasone HFA	“Fluticasone HFA alone at 44mcg, 110mcg or 220 mcg 2 puffs every 12 hrs, over 16 week study period.” NCT00521222 ↗
Known as	Fluticasone Propionate	“Fluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of 2 inhalations twice daily among participants aged 12 to \<18 years up...” NCT00550550 ↗ 16 “The inhaled corticosteroid (ICS) fluticasone propionate (fluticasone) and the long-acting β2-agonist (LABA) formoterol fumarate (formoterol) are being made available as a...” PMID 21605396 ↗ May 2011 “receive 750 microg of fluticasone propionate (ex-valve [manufacturer-measured] dose) or placebo twice daily, beginning at the onset of an upper respiratory tract infection and...” PMID 19164187 ↗ Jan 2009 “The potent inhaled corticosteroid, fluticasone propionate (fluticasone), and the long-acting β2-agonist with a rapid onset of action, formoterol fumarate (formoterol)” PMID 23368897 ↗ Feb 2013 “COMP = Fluticasone Propionate Nasal Spray, Roxane Laboratories = FLU mono Fluticasone propionate nasal spray (= US marketed product)” NCT01194622 ↗ “It had been shown previously that steady state plasma levels can be achieved in 3 days when using fluticasone propionate.” NCT00830505 ↗ “Thirty subjects with mild to moderate asthma will receive inhaled fluticasone propionate.” NCT00409630 ↗ “Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®” NCT01636076 ↗ “fluticasone propionate / formoterol spray (flutiform®) 200/20 micrograms per day” NCT02063139 ↗ “allocated to 500 mcg fluticasone propionate twice daily (n = 128), or placebo” PMID 18162137 ↗ Dec 2007 “twice-daily doses of 186 and 372 µg of OPN-375 (fluticasone propionate)” NCT03960580 ↗ Show 6 more sources
Known as	Fluticasone, cream	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01772056 ↗
Known as	Fluticasone/salmeterol (FSC)	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02924688 ↗
Known as	Fluticasone/salmeterol combination	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03387852 ↗
Known as	OPN-375	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03960580 ↗ 2 NCT03747458 ↗ NCT03781804 ↗
Modality	Other / unclassified	“inhaled corticosteroid (ICS) therapy” NCT00156819 ↗
Route	Inhaled	“fluticasone administered with a dry-powder inhaler” NCT00079937 ↗