Salmeterol
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asthma 1 milestone | |||||
| Filed | EU (EMA) | — | asthma | — | “In April 2017 Orion submitted a marketing authorisation application for a salmeterol-fluticasone combined formulation in Europe” orionpharma.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Aerivio Spiromax | — | 2016-08-18 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Labazenit | — | 2013-09-06 | europa.eu ↗ |
Trials 147 · started per year
| 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 115 trials · 1 met primary | ||||||
| Phase 1 | NCT04195867 | Nov 2018 → Jan 2019 | — | Parc de Salut Mar | Completed | No outcome recorded |
| 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 | 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| Phase 1 | NCT02218762 | Oct 2014 → Jun 2015 | asthma | GlaxoSmithKline | Withdrawn | No outcome recorded |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 | 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 | NCT01521455 | Feb 2012 → Jun 2013 | asthma | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT01540708 | Jan → Sep 2012 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02254174 | Mar → Jul 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02254187 | Sep → Oct 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00364273 | Aug 2005 → Jul 2006 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00364442 | Jan → Apr 2005 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02254226 | Nov 2004 → Jan 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06040268 | Dec 2023 → Dec 2026 expected | high altitude pulmonary edema | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 1/2 | NCT01494610 | Oct 2010 → Jun 2011 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 215 trials · 5 met primary | ||||||
| Phase 2 | NCT02833480 | Feb 2015 → Jan 2021 | chronic obstructive pulmonary disease | University of British Columbia | Unknown | No outcome recorded |
| Phase 2 | NCT01802723 | Feb → Jun 2013 | lipodystrophy | Neothetics, Inc | Completed | No outcome recorded |
| Phase 2 | NCT01048333 | Jan → May 2010 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| 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 | NCT00531050 | Aug 2007 → Jun 2008 | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00468975 | May 2007 → ? | asthma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00403754 | Nov 2006 → Nov 2007 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00422604 | Oct 2006 → May 2007 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00350207 | Jul 2006 → Sep 2008 | asthma | Boehringer Ingelheim | Completed | Met primary |
| Phase 2 | NCT00358488 | Apr 2006 → Jan 2007 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00325169 | Dec 2005 → Aug 2006 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT02238106 | Sep 2005 → Feb 2006 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02242227 | Sep 2005 → Feb 2006 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02242253 | Sep 2003 → Jul 2004 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 339 trials · 7 met primary · 2 missed | ||||||
| Phase 3 | NCT05776927 | Aug 2026 → Dec 2028 expected | asthma | Novartis Pharmaceuticals | Recruiting | 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 | 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 | NCT03461627 | Apr 2017 → Oct 2018 | asthma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT02980133 | Dec 2016 → Apr 2019 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Mixed |
| 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 | NCT02175771 | Jul 2014 → Jul 2015 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| 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 | NCT01795664 | Mar → Aug 2013 | asthma | FLUIDDA nv | Completed | No outcome recorded |
| Phase 3 | NCT01079130 | Feb → Jul 2010 | asthma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00673478 | May 2008 → Jun 2009 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00668772 | Apr → Nov 2008 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 3 | NCT00662792 | Apr 2008 → Jul 2009 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | Mixed |
| Phase 3 | NCT01484210 | Mar → Aug 2008 | asthma | Elpen Pharmaceutical Co. Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00622635 | Jan → Jul 2008 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00615030 | Jan → Jul 2008 | chronic obstructive pulmonary disease | Novartis | Completed | Met primary |
| Phase 3 | NCT00529529 | Sep 2007 → Aug 2008 | asthma | Novartis Pharmaceuticals | 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 | 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 | NCT00245570 | Dec 2005 → Sep 2006 | exercise-induced bronchoconstriction | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00127166 | Dec 2005 → Nov 2008 | exercise-induced bronchoconstriction | Organon and Co | Completed | Met primary |
| Phase 3 | NCT00328718 | Oct 2005 → Apr 2007 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00242775 | May 2005 → May 2006 | asthma | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT00269126 | Feb → Aug 2005 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00252863 | Dec 2004 → May 2006 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00200967 | Dec 2004 → Feb 2008 | asthma | Milton S. Hershey Medical Center | Completed | Missed 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 | NCT00272506 | Aug 2002 → Sep 2004 | asthma, lung disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00274560 | May 2002 → Mar 2003 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00920959 | Nov 2001 → Jan 2004 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00274534 | Dec 2000 → Jul 2003 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00268216 | Sep 2000 → Nov 2005 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 461 trials · 12 met primary · 8 missed | ||||||
| Phase 4 | NCT04503460 | Jul 2021 → Sep 2024 | asthma | Imperial College London | Unknown | No outcome recorded |
| Phase 4 | NCT04677959 | Feb 2021 → Mar 2022 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT03662711 | Nov 2018 → Oct 2022 | chronic obstructive pulmonary disease | Università degli Studi di Ferrara | Terminated | 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 | NCT03269318 | Jul 2017 → Aug 2019 | asthma | Brighton and Sussex University Hospitals NHS Trust | Terminated | No outcome recorded |
| Phase 4 | NCT03034915 | Jun 2017 → Jun 2018 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT02558088 | Sep 2014 → Jul 2016 | — | University of Copenhagen | Completed | 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 | NCT01853787 | Jul 2014 → Jun 2015 | chronic obstructive pulmonary disease | University of Milan | Completed | No outcome recorded |
| Phase 4 | NCT02055352 | May 2014 → Jan 2016 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT02113436 | May 2014 → Jun 2016 | asthma | GlaxoSmithKline | Completed | Missed primary |
| Phase 4 | NCT02061280 | Oct 2013 → Feb 2017 | asthma | Nemours Children's Clinic | Completed | Mixed |
| Phase 4 | NCT01794780 | Feb 2013 → May 2015 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01762800 | Feb 2013 → Sep 2015 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01536587 | Jul → Nov 2012 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 4 | NCT01607398 | May 2012 → Jul 2013 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 4 | NCT01475721 | Nov 2011 → Jun 2015 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT01462344 | Nov 2011 → Nov 2015 | asthma | GlaxoSmithKline | Completed | Mixed |
| Phase 4 | NCT01361984 | Jun 2011 → Jun 2013 | chronic bronchitis, pulmonary emphysema | University of California, Los Angeles | Unknown | No outcome recorded |
| Phase 4 | NCT02782312 | Jun 2011 → Jun 2012 | bronchiectasis | Shanghai Pulmonary Hospital, Shanghai, China | Completed | No outcome recorded |
| Phase 4 | NCT01192178 | Aug → Dec 2010 | asthma | 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 | 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 | NCT00984659 | Oct 2009 → Jul 2010 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Mixed |
| Phase 4 | NCT00914901 | Jul 2009 → Mar 2011 | asthma | Bispebjerg Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00901368 | May 2009 → Sep 2010 | asthma | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 4 | NCT00830505 | Apr 2009 → May 2010 | asthma | University of Dundee | Completed | Met primary |
| Phase 4 | NCT01526161 | Apr 2009 → Jun 2010 | asthma | Professor Warren Lenney | Completed | No outcome recorded |
| Phase 4 | NCT00784550 | Dec 2008 → Dec 2009 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT00867737 | Sep 2008 → Sep 2009 | asthma | Allergy and Asthma Center of El Paso | Unknown | 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 | NCT00633217 | Mar 2008 → Feb 2009 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00530842 | Sep 2007 → Jan 2009 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | Mixed |
| Phase 4 | NCT00517634 | Aug 2007 → Jul 2008 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00712335 | Feb 2007 → May 2011 | environmental induced asthma | Inje University | Completed | No outcome recorded |
| 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 | 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 | 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 | NCT00120978 | Dec 2004 → Aug 2006 | chronic obstructive pulmonary disease | University of British Columbia | Unknown | Missed primary |
| Phase 4 | NCT00115492 | Dec 2004 → Jun 2007 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT00315744 | Nov 2004 → Apr 2007 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| 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 | NCT00327353 | Jan 2004 → ? | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00118716 | Dec 2003 → Apr 2006 | exercise-induced bronchoconstriction | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT00118690 | Dec 2003 → Dec 2005 | exercise-induced bronchoconstriction | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00239421 | Nov 2003 → Sep 2004 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | Met primary |
| Phase 4 | NCT00239499 | Sep 2003 → Aug 2004 | chronic obstructive pulmonary disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT00950794 | Sep 2003 → Feb 2005 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00156819 | Jun 2003 → Aug 2005 | asthma | JHSPH Center for Clinical Trials | Completed | Missed primary |
| Phase 4 | NCT00361959 | Jun 2003 → Feb 2006 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00479739 | Nov 2002 → Jul 2004 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT00158847 | Apr 2000 → May 2005 | chronic obstructive pulmonary disease | Leiden University Medical Center | Terminated | Met primary |
| Phase not applicable14 trials · 2 met primary | ||||||
| — | NCT06654986 | Oct 2024 → Dec 2026 expected | — | University of Copenhagen | Recruiting | No outcome recorded |
| — | NCT06657547 | Oct 2024 → Dec 2026 expected | — | University of Copenhagen | Recruiting | No outcome recorded |
| — | NCT06655012 | Oct 2024 → Dec 2026 expected | — | University of Copenhagen | Recruiting | No outcome recorded |
| — | NCT03524066 | Apr → Dec 2018 | — | Fraunhofer-Institute of Toxicology and Experimental Medicine | Completed | No outcome recorded |
| — | NCT02758873 | Feb 2016 → Jul 2019 | asthma | University of Sussex | Completed | Met primary |
| — | NCT01933984 | Aug 2013 → Jan 2019 | chronic obstructive pulmonary disease | Shin-hwar Wu | Completed | No outcome recorded |
| — | NCT01271556 | Dec 2008 → Mar 2009 | chronic obstructive pulmonary disease | University of Milan | Completed | 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 |
| — | NCT01231230 | May 2007 → Dec 2009 | asthma | University of Miami | Completed | Met primary |
| — | NCT00736801 | Sep 2005 → Jan 2007 | allergic asthma | University of Rostock | Completed | No outcome recorded |
| — | NCT00214019 | Nov 2003 → Jan 2008 | allergic asthma | University of Wisconsin, Madison | Completed | No outcome recorded |
| — | NCT00233051 | Apr 2003 → Jun 2006 | chronic bronchitis, pulmonary emphysema | National Jewish Health | Terminated | No outcome recorded |
| — | NCT00005110 | — | cystic fibrosis | National Center for Research Resources (NCRR) | Suspended | No outcome recorded |
| Comparator or background therapy131 trials | ||||||
| Phase 1 | NCT02474017 Background | May → Jun 2015 | asthma, chronic obstructive pulmonary disease | Mylan Pharma UK Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02162485 Comparator | Jun 2014 → Sep 2015 | asthma | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT01355991 Comparator | Aug 2011 → Mar 2016 | spinal cord injury | James J. Peters Veterans Affairs Medical Center | Unknown | No outcome recorded |
| Phase 1 | NCT00908362 Comparator | May → Oct 2009 | chronic obstructive pulmonary disease | University of Rostock | Completed | No outcome recorded |
| Phase 1 | NCT02256722 Comparator | Oct → Nov 2005 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Show all 131 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 37
| Date | Issuer | Release |
|---|---|---|
| 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 . |
| 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 ↗ |
| 2018-03-19 | 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). |
| 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]. |
| 2017-06-15 | 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]. |
| 2017-04-26 | 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. |
| 2016-09-05 | Boehringer Ingelheim | Results Simple Blood Test Combined with Exacerbation History May Help to Identify When to Add ICS to COPD Treatment prnewswire.com ↗
It suggests that only 4 in 100 people of the study population – with a history of frequent exacerbations and raised eosinophil levels (≥400 cells/µL) – may benefit by adding ICS to SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder) and a long-acting beta 2 -agonist (salmeterol) to further reduce the risk of exacerbations. |
| 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. |
| 2016-05-16 | 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]. |
| 2016-04-08 | Boehringer Ingelheim | Results Lancet Publication: New Analysis Demonstrates Only Small Minority of Severe/Very Severe COPD Patients May Benefit from Adding ICS to SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder) + LABA Therapy prnewswire.com ↗
For 80 percent of patients in the WISDOM study, the use of ICS on top of SPIRIVA® HANDIHALER® ‡ and a LABA** had no additional benefit in reducing the risk of exacerbations or 'flare-ups,' compared to SPIRIVA® HANDIHALER® ‡ and a LABA without ICS. |
| 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. |
| 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. |
| 2015-11-19 | 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. |
| 2015-09-28 | 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. |
| 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. |
| 2013-09-10 | Boehringer Ingelheim | Results Data for Investigational Tiotropium Show Improved Lung Function and Sustained Bronchodilation in Patients with Moderate Asthma Severity prnewswire.com ↗
In the individual trials and the pooled analysis being presented at ERS, the mean change in peak FEV 1 at 24 weeks from baseline versus placebo was significantly improved for all three active treatments: |
| 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): |
| 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. |
| 2010-06-02 | AstraZeneca | Regulatory FDA updates US product labels for LABA-containing medications including AstraZeneca’s SYMBICORT astrazeneca.com ↗
Today, the US Food and Drug Administration (FDA) released final label revisions for respiratory medications that contain an active ingredient known as a long-acting beta-agonist (LABA). |
| 2010-06-01 | GlaxoSmithKline | Regulatory GSK announces revised product labels for Serevent and Advair gsk.com ↗
GlaxoSmithKline [NYSE:GSK] 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). |
All press releases naming this drug 39 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 284 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Salmeterol | “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 ↗279“This pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone, salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250...” NCT02441114 ↗ “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 “Dual Therapy (LABA + LAMA): Patients receive a long-acting beta-agonist (LABA) such as Formoterol, Salmeterol, Olodaterol, Vilanterol, or Indacaterol, in combination with a...” NCT07058259 ↗ “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 ↗ “Salmeterol xinafoate Inhalation Powder (SEREVENT DISKUS) is indicated for the long-term, twice-daily (morning and evening), administration in the maintenance treatment of...” NCT01110200 ↗ “compare Systemic Exposure and Pharmacodynamics of Fluticasone Propionate and Salmeterol Following Advair HFA 45/21mcg (2 Inhalations), ADVAIR® HFA 45/21mcg (2 Inhalations) With...” NCT00400608 ↗ “Effectiveness of Fluticasone Furoate/ Umeclidinium/ Vilanterol (FF/UMEC/VI) Using the Connected Inhaler System (CIS) as Compared With Fluticasone Proprionate/ Salmeterol...” NCT03376932 ↗ “The combination of salmeterol and fluticasone propionate (SFC) and tiotropium bromide (TIO) are commonly used treatments in chronic obstructive pulmonary disease (COPD) but...” PMID 18245142 ↗ Feb 2008 |
| Known as | 408DP-02 | “Salmeterol(408DP-02):long-acting Beta2-agonist” NCT00950794 ↗ |
| Known as | SAL | “The aim of this study was to compare the efficacy of FF/VI with fluticasone propionate (FP)/salmeterol (SAL) in patients with persistent asthma uncontrolled on a medium dose of ICS.” PMID 23846316 ↗ Oct 20136“Subjects were randomized (1:1) to receive fluticasone propionate/salmeterol (FP/SAL) 100/50 mcg or FP 100 mcg prior to starting school.” PMID 26289742 ↗ Jun 2015 “salmeterol/fluticasone propionate (SFC) and salmeterol (SAL) that had primary endpoints of moderate/severe exacerbation rates” PMID 23613569 ↗ Apr 2013 “fluticasone propionate/salmeterol (FP/SAL) (inhaled corticosteroid/LABA)” PMID 26006754 ↗ May 2015 “salmeterol/fluticasone propionate (SAL/FP) 50/500 µg twice daily” PMID 25841237 ↗ Apr 2015 “An active control arm received salmeterol (SAL) twice daily.” PMID 24928338 ↗ Jun 2014 “fluticasone propionate/salmeterol 250/50 µg (FP/SAL)” PMID 28961020 ↗ Apr 2018 |
| Known as | SAL 50 | “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 | Salm | “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 ↗2“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 “high-dose salmeterol (SALM)/fluticasone (FP) maintenance plus an as-needed short-acting β(2)-agonist in Chinese patients with persistent uncontrolled asthma” PMID 22932169 ↗ Sep 2012 |
| Known as | Salm25PE | “salmeterol (Salm25PE)” NCT00668772 ↗ |
| Known as | Salm50DPI | “50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID)” NCT00662792 ↗ |
| Known as | salmeterol xinafoate | “Salmeterol xinafoate Inhalation Powder (SEREVENT DISKUS) is indicated for the long-term, twice-daily (morning and evening), administration in the maintenance treatment of...” NCT01110200 ↗12“Capsules containing salmeterol xinafoate 72.5 µg (equivalent to 50 µg of salmeterol) presented as powder for aspiration, packed in a plastic device in disk format, containing 60 doses” NCT01393145 ↗ “The DISKUS inhaler will contain one blister strip, which will have 60 blisters of salmeterol xinafoate (50 mcg).” NCT03034915 ↗ “Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.” NCT00355342 ↗ “Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®” NCT01636076 ↗ “fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate” NCT00975195 ↗ “Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg” NCT02441114 ↗ “Salmeterol xinafoate and Fluticasone propionate HFA pMDI” NCT01795664 ↗ “Fluticasone propionate (FP)/ Salmeterol xinafoate (SLM)” NCT02113436 ↗ “Serevent (salmeterol xinafoate inhalation powder)” NCT01361984 ↗ “Drug: Salmeterol xinafoate” NCT02242227 ↗ |
| Known as | Salmetrol Xinafoate | “Salmeterol Product Name: Serevent® Manufacturer: Allan and Hanbury's Active ingredients: Salmetrol Xinafoate Propellant: HFA 134a Dose: 25μg per actuation giving a total dose...” NCT01388595 ↗ |
| Known as | Serevent | “Salmeterol Product Name: Serevent® Manufacturer: Allan and Hanbury's Active ingredients: Salmetrol Xinafoate Propellant: HFA 134a Dose: 25μg per actuation giving a total dose...” NCT01388595 ↗5“Thus, the primary objective for the present study is to compare the two extremes of available long acting beta-agonist formulations - i.e. extra fine HFA formoterol ( Atimos )...” NCT01892787 ↗ “Pharmacokinetics of Salmeterol (Serevent®) After Inhalation With Metered Dose Inhaler (MDI) and Diskus® in Healthy Male Volunteers” NCT02254226 ↗ “Salmeterol 50 mcg (Serevent) via Diskus dry powder inhaler” NCT01361984 ↗ “Salmeterol 25 µg pMDI HFA (Serevent™)” NCT01344655 ↗ “salmeterol (Serevent, 50 µg b.i.d.)” NCT00239499 ↗ |
| Known as | Serevent Diskus | “A Randomised, Open-label Three-way Crossover Study to Evaluate the Pharmacokinetics of Salmeterol After Inhalation of a 25 μg and 50 μg Single Dose (Inhalation Powder, Hard PE...” NCT02254187 ↗3“Salmeterol xinafoate Inhalation Powder (SEREVENT DISKUS) is indicated for the long-term, twice-daily (morning and evening), administration in the maintenance treatment of...” NCT01110200 ↗ “a Free Combined Single Dose of 18 μg Tiotropium [Spiriva® HandiHaler®] and 50 μg Salmeterol [Serevent® Diskus®]” NCT02254174 ↗ “SEREVENT DISKUS® (Salmeterol) Inhlaer” NCT00346749 ↗ |
| Known as | SLM | “Fluticasone propionate (FP)/ Salmeterol xinafoate (SLM)” NCT02113436 ↗ |
| Known as | SN408D | “Salmeterol(SN408D):long-acting Beta2-agonist” NCT00950794 ↗ |
| Action | Activate | “a long-acting beta-agonist” NCT00156819 ↗ |
| Modality | Other / unclassified | “a long-acting beta-agonist” NCT00156819 ↗ |
| Route | Inhaled | “one group will get Salmeterol by multi-dose inhaler (MDI) 2 puffs 2 times a day” NCT00005110 ↗ |