Fluticasone Furoate
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asthma 2 milestones | |||||
| Filed | EU (EMA) | Relvar Ellipta | asthma | 2017-07-21 | “submission to the European Medicines Agency (EMA) for the extended use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI)” gsk.com ↗ |
| Filed | US (FDA) | — | asthma | 2013-10-23 | “today announced the submission of a New Drug Application (NDA) in the US for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF)” gsk.com ↗ |
| Filed chronic obstructive pulmonary disease 3 milestones | |||||
| Filed | EU (EMA) | — | chronic obstructive pulmonary disease | 2016-12-02 | “filing by GSK of a regulatory submission with the European Medicines Agency for once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol” gsk.com ↗ |
| Filed | US (FDA) | — | chronic obstructive pulmonary disease | 2016-11-21 | “filing by GSK of a regulatory submission with the US Food and Drug Administration for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol” gsk.com ↗ |
| Filed | US (FDA) | — | chronic obstructive pulmonary disease | 2012-09-26 | “for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the US Food and Drug Administration (FDA)” gsk.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (2) | US (FDA) | ARNUITY ELLIPTA | — | 2018-05-17 – 2023-03-01 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | FLONASE SENSIMIST ALLERGY RELIEF | — | 2012-08-21 – 2016-08-02 | fda.gov ↗ |
| Approved | EU (EMA) | Avamys | — | 2008-01-11 | europa.eu ↗ |
| Approved | US (FDA) | FLONASE SENSIMIST ALLERGY RELIEF | — | 2007-04-27 | fda.gov ↗ |
Trials 126 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 121 trials | ||||||
| Phase 1 | NCT02837380 | Sep → Nov 2016 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02666287 | Jan → Jun 2016 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02064504 | Feb → May 2014 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01837316 | Oct 2013 → Aug 2014 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01962467 | Oct 2013 → Feb 2014 | allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01894386 | Jul → Sep 2013 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01691547 | Dec 2012 → Mar 2013 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01711463 | Dec 2012 → Jun 2013 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01725685 | Nov 2012 → Jan 2013 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01669070 | Aug → Nov 2012 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01266980 | Nov 2010 → Mar 2011 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01213849 | Oct → Nov 2010 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01165125 | Jul → Aug 2010 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01209026 | Jun 2010 → Jan 2011 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01299558 | May → Jul 2010 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01000597 | Sep → Dec 2009 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00972673 | Sep → Dec 2008 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00538057 | Oct → Dec 2007 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00444509 | Feb → Apr 2007 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00522678 | Feb → Apr 2007 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00419237 | Jan → Apr 2005 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 215 trials · 9 met primary | ||||||
| Phase 2 | NCT03739294 | Feb 2019 → Dec 2020 | — | Bispebjerg Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02991859 | Feb 2017 → Dec 2018 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02712047 | Apr 2016 → Feb 2017 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT02573870 | Dec 2015 → Jul 2016 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02164539 | Jul 2014 → Jul 2015 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT01957202 | Oct 2013 → Feb 2014 | allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT01808339 | Mar 2013 → Mar 2014 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT01287065 | Oct 2010 → Sep 2011 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01018030 | Jan → Jul 2010 | sinusitis | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT00766090 | Oct 2008 → Mar 2009 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT00603382 | Dec 2007 → Oct 2008 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT00603746 | Dec 2007 → Sep 2008 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT00603278 | Dec 2007 → Nov 2008 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT00398645 | Nov 2006 → Aug 2007 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01499446 | Sep 2003 → Mar 2004 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 360 trials · 25 met primary · 10 missed | ||||||
| Phase 3 | NCT07223294 | Apr 2026 | respiratory system disorder | Sandoz | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04651777 | Aug 2022 → Aug 2023 overdue | asthma | Dr. Grace Parraga | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03376932 | Jan 2019 → Feb 2021 | asthma | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 3 | NCT03248128 | Oct 2017 → Mar 2022 | asthma | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT03184987 | Jun 2017 → Jun 2019 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02924688 | Oct 2016 → Feb 2019 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02729051 | Jun 2016 → May 2017 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02483975 | Oct 2015 → Jun 2016 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02502734 | Sep → Dec 2015 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02446418 | Jul 2015 → Jul 2017 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02301975 | Mar 2015 → Nov 2016 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02345161 | Jan 2015 → Apr 2016 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT02164513 | Jun 2014 → Jul 2017 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02105974 | Apr 2014 → Jul 2015 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02094937 | Mar 2014 → Aug 2015 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01706198 | Nov 2012 → Dec 2016 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01691885 | Nov 2012 → Jul 2014 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01706328 | Oct 2012 → Jun 2013 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT01686633 | Sep 2012 → Oct 2013 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01622231 | Jun → Nov 2012 | rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01630135 | Jun → Aug 2012 | perennial allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01551758 | Mar 2012 → Nov 2015 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01498653 | Jan 2012 → Feb 2013 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01431950 | Sep 2011 → Oct 2012 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01436071 | Sep 2011 → Jun 2012 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01436110 | Sep 2011 → Sep 2012 | asthma | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT01395888 | Jun 2011 → Aug 2012 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT01323621 | Mar 2011 → Jan 2012 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT01323634 | Mar → Dec 2011 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01336608 | Mar 2011 → Nov 2014 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT01342913 | Feb → Oct 2011 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT01313676 | Jan 2011 → Jul 2015 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT01279057 | Dec 2010 → Feb 2011 | seasonal allergic rhinitis | Sandoz | Completed | Met primary |
| Phase 3 | NCT01165138 | Aug 2010 → Oct 2011 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01192191 | Aug 2010 → Jan 2012 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01244984 | Jul 2010 → Jan 2012 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01159912 | Jun 2010 → Jan 2012 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01147848 | Jun 2010 → Jul 2011 | asthma | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT01086384 | Feb 2010 → Sep 2011 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01072149 | Jan → Jul 2010 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01018186 | Oct 2009 → May 2011 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01054885 | Oct 2009 → Feb 2011 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01017952 | Sep 2009 → Oct 2011 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01009463 | Sep 2009 → Oct 2011 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT01231464 | Sep 2009 → May 2010 | perennial allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00289198 | Feb → Jul 2006 | perennial allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00224523 | Sep 2005 → Feb 2007 | perennial allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00197262 | Aug → Oct 2005 | seasonal allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00117325 | Jul 2005 → Feb 2006 | vasomotor rhinitis | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00118703 | Jul 2005 → Feb 2006 | vasomotor rhinitis | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00225823 | May → Aug 2005 | seasonal allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00109486 | Apr → Nov 2005 | allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00118729 | Apr → Aug 2005 | seasonal allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00107757 | Mar → Nov 2005 | perennial allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00363740 | Feb → Apr 2005 | seasonal allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00116883 | Feb → Jul 2005 | perennial allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00108914 | Feb → Nov 2005 | perennial allergic rhinitis | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT00116818 | Jan → May 2005 | perennial allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00103454 | Jan → May 2005 | perennial allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00115622 | Dec 2004 → Jan 2005 | seasonal allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 426 trials · 8 met primary · 3 missed | ||||||
| Phase 4 | NCT07192016 | Mar 2026 → Sep 2027 expected | chronic obstructive pulmonary disease | Western University, Canada | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06552364 | Apr 2025 → Dec 2026 expected | chronic obstructive pulmonary disease | University of British Columbia | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06372496 | Apr 2024 → Jul 2025 overdue | asthma | GlaxoSmithKline | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04923347 | Jun 2023 → Mar 2024 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT05651750 | Nov 2022 → May 2023 | — | Assaf-Harofeh Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT05535972 | Oct 2022 → Sep 2023 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT05292053 | Jul 2022 → Sep 2024 | chronic obstructive pulmonary disease | Baylor Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT03949842 | Jun 2019 → Nov 2022 | chronic obstructive pulmonary disease | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03898466 | Oct 2018 → Apr 2019 | asthma | University of Saskatchewan | Completed | No outcome recorded |
| Phase 4 | NCT03478696 | Jun 2018 → Mar 2019 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT03467425 | Apr 2018 → Oct 2019 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT03474081 | Mar 2018 → Jul 2019 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT03315000 | Oct 2017 → May 2018 | asthma | University of Saskatchewan | Completed | No outcome recorded |
| Phase 4 | NCT02889809 | Jul 2017 → Apr 2021 | asthma | GlaxoSmithKline | Completed | Missed primary |
| Phase 4 | NCT02730351 | May 2016 → Feb 2017 | asthma | GlaxoSmithKline | Completed | Missed primary |
| Phase 4 | NCT02424539 | Sep 2015 → Oct 2017 | perennial allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT02397915 | Mar → Jun 2015 | allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT01957150 | Jan 2014 → Mar 2018 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00997620 | Mar → Sep 2010 | seasonal allergic rhinitis | Western Sky Medical Research | Completed | No outcome recorded |
| Phase 4 | NCT01007253 | Nov 2009 → Apr 2010 | seasonal allergic rhinitis | University of Chicago | Completed | Met primary |
| Phase 4 | NCT01270958 | Aug 2009 → Feb 2010 | perennial allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00609674 | Jan → Jun 2008 | perennial allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT00570492 | Nov 2007 → Mar 2011 | perennial allergic rhinitis | GlaxoSmithKline | Completed | Missed primary |
| Phase 4 | NCT00502775 | Aug → Nov 2007 | seasonal allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT00473915 | Apr → Dec 2007 | seasonal allergic rhinitis | University of Chicago | Completed | No outcome recorded |
| Phase 4 | NCT00435461 | Dec 2006 → Feb 2007 | seasonal allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase not applicable4 trials | ||||||
| — | NCT06066606 | Oct 2023 → Jul 2026 overdue | — | Morten Hostrup, PhD | Recruiting | No outcome recorded |
| — | NCT06077019 | Oct 2023 → Jul 2026 overdue | — | Morten Hostrup, PhD | Recruiting | No outcome recorded |
| — | NCT01562093 | Jan 2012 → Jun 2016 | asthma | St. Olavs Hospital | Terminated | No outcome recorded |
| — | NCT01318681 | Jan 2011 → Mar 2012 | seasonal allergic rhinitis | Maastricht University Medical Center | Completed | No outcome recorded |
| Comparator or background therapy39 trials | ||||||
| Phase 0 | NCT05381207 Comparator | Oct 2022 → Oct 2024 | allergic rhinitis | Assiut University | Unknown | No outcome recorded |
| Phase 1 | NCT02218723 Comparator | Oct → Dec 2014 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/2 | NCT05143502 Background | Jan 2022 → Jan 2024 | chronic rhinosinusitis | Assiut University | Unknown | No outcome recorded |
| Phase 2 | NCT04072887 Background | Sep 2019 → Oct 2021 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT03622112 Comparator | Jan → Sep 2019 | asthma | AstraZeneca | Completed | Missed primary |
| Phase 2 | NCT03012061 Background | Jan 2017 → May 2018 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT01573624 Comparator | Apr 2012 → Feb 2013 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT01563029 Comparator | Mar 2012 → Sep 2014 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01453023 Comparator | Oct 2011 → Jun 2012 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01332292 Comparator | May 2010 → Jan 2011 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01128595 Comparator | May 2010 → May 2011 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01128569 Comparator | Jan → Oct 2010 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00730756 Comparator | Mar 2008 → Feb 2009 | perennial allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT05757102 Background | Apr 2023 → Jan 2027 expected | asthma | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT05299086 Comparator | Apr 2022 → Mar 2025 | perennial allergic rhinitis | Mahidol University | Completed | No outcome recorded |
| Phase 3 | NCT05276336 Background | Jul 2018 → Feb 2020 | allergic rhinitis | Indonesia University | Completed | No outcome recorded |
| Phase 3 | NCT02731846 Background | Jun → Nov 2016 | chronic obstructive pulmonary disease | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 3 | NCT02467452 Comparator | May 2015 → Jan 2017 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT01957163 Background | Oct 2013 → Apr 2014 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02119286 Background | Oct 2013 → Apr 2014 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01498679 Comparator | Jan 2012 → Jul 2013 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01435902 Comparator | Jan → Aug 2012 | asthma | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01134042 Comparator | Jun 2010 → Oct 2011 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00398476 Comparator | Dec 2006 | perennial allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT03363191 Comparator | Mar 2018 → May 2019 | asthma | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 4 | NCT03380429 Background | Jan 2018 → Jan 2019 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT05342558 Comparator | Sep 2017 → Nov 2020 | chronic obstructive pulmonary disease | National Institute of Respiratory Diseases, Mexico | Completed | No outcome recorded |
| Phase 4 | NCT03152149 Comparator | Jun 2017 → Nov 2019 | chronic obstructive pulmonary disease | University of Dundee | Completed | No outcome recorded |
| Phase 4 | NCT01013701 Comparator | Nov 2009 → Jul 2010 | nasal cavity polyp | Johns Hopkins University | Terminated | No outcome recorded |
| Phase 4 | NCT00891436 Comparator | Apr → Jul 2009 | eye allergy | Rush University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00791973 Comparator | Nov 2008 → Apr 2009 | allergic rhinitis | University of Chicago | Completed | No outcome recorded |
| Phase 4 | NCT00682643 Comparator | Jun 2008 → Feb 2011 | perennial allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00603044 Comparator | Jan 2008 → Jan 2009 | obstructive sleep apnea syndrome | University of Chicago | Completed | No outcome recorded |
| Phase 4 | NCT00539006 Comparator | Aug → Nov 2007 | perennial allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00519636 Comparator | Aug → Nov 2007 | perennial allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00584987 Comparator | Jun 2007 → Jul 2009 | allergic rhinitis | University of Chicago | Completed | No outcome recorded |
| Phase 4 | NCT01076439 Comparator | — | allergic rhinitis | ORA, Inc. | Withdrawn | No outcome recorded |
| — | NCT04621513 Background | Jul 2020 → Dec 2021 | obstructive sleep apnea syndrome | China Medical University Hospital | Unknown | No outcome recorded |
| — | NCT03673384 Background | Mar 2015 → Jul 2017 | allergic rhinitis | Nanhua University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 38
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2020-09-09 | GlaxoSmithKline | Regulatory FDA approves Trelegy Ellipta as the first once-daily single inhaler triple therapy for the treatment of both asthma and COPD in the US gsk.com ↗
The FDA-approved strength for both COPD and asthma is fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg. |
| 2020-02-27 | GlaxoSmithKline | Regulatory GSK filing accepted by European Medicines Agency for Trelegy Ellipta use in adult patients with asthma gsk.com ↗
today announced the acceptance of a regulatory submission seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) |
| 2018-05-29 | GlaxoSmithKline | Regulatory GSK submits regulatory application in Japan for once-daily single inhaler triple therapy FF/UMEC/VI for patients with COPD gsk.com ↗
We are delighted to have filed a new drug application for the first single inhaler triple therapy for the treatment of COPD in Japan where the prevalence of COPD is of public concern. |
| 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. |
| 2018-04-18 | GlaxoSmithKline | Results Landmark IMPACT study published in NEJM shows significant benefits of Trelegy Ellipta for patients with COPD gsk.com ↗
A 42.1% reduction in the risk of on-treatment all-cause mortality was observed for Trelegy compared to Anoro (1.20% vs. 1.88%; p=0.011). |
| 2018-03-08 | GlaxoSmithKline | Regulatory GSK announces positive EU approval for labelling update to Relvar Ellipta in patients with asthma gsk.com ↗
We welcome this approval, which signifies an important milestone for Relvar Ellipta. |
| 2018-02-15 | Theravance Biopharma | Regulatory Theravance Biopharma Highlights Submission of Landmark IMPACT Data to EMA to Support Expanded Label for Trelegy Ellipta theravance.com ↗
Theravance Biopharma, Inc. (NASDAQ: TBPH) (" Theravance Biopharma ") today highlighted the submission of the landmark IMPACT study data to the European Medicines Agency (EMA) as part of a type II variation to support an expanded label for Trelegy Ellipta in Europe for the maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD). |
| 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 ↗
The FDA also approved updates to the Warnings and Precautions section of labelling for the ICS/LABA class. |
| 2017-09-20 | GlaxoSmithKline | Results GSK and Innoviva report positive headline results from IMPACT study showing single inhaler triple therapy Trelegy Ellipta reduced COPD exacerbations gsk.com ↗ |
| 2017-09-15 | GlaxoSmithKline | Regulatory Trelegy Ellipta once-daily single inhaler triple therapy receives positive opinion from the CHMP in Europe for appropriate patients with COPD gsk.com ↗ |
| 2017-09-11 | GlaxoSmithKline | Results Positive results from pioneering Salford Lung Study in asthma published in The Lancet, and presented at European Respiratory Congress gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced positive results from the Salford Lung Study (SLS) in asthma have been simultaneously published in The Lancet journal and presented at the European Respiratory Society (ERS) International Congress in Milan. |
| 2017-07-24 | GlaxoSmithKline | Regulatory GSK submits US regulatory filing of Arnuity Ellipta in children with asthma gsk.com ↗
Today’s submission includes data from a pivotal study assessing the efficacy and safety of once daily fluticasone furoate, compared to placebo, in 593 children aged 5 to 11 years (inclusive) with asthma. |
| 2017-05-05 | GlaxoSmithKline | Results Relvar Ellipta significantly improved asthma control in Salford Lung Study patients compared with their usual care gsk.com ↗
This open-label, randomised study showed that significantly more asthma patients initiated on treatment with Relvar Ellipta 100/25mcg or 200/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) achieved an improvement in their asthma control compared with patients who continued to take their usual care medicines. |
| 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. |
| 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). |
| 2016-09-06 | GlaxoSmithKline | Results GSK presents positive results from phase III FULFIL study of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in COPD at ERS International Congress gsk.com ↗
In addition, the proportion of patients who responded with the minimum clinically important difference in SGRQ (-4 units) was 50% on closed triple and 41% on budesonide/formoterol (odds ratio 1.41; p<0.001). |
| 2016-09-04 | GlaxoSmithKline | Results GSK announce positive results from the COPD Salford Lung Study published in the NEJM and presented at European Respiratory Congress gsk.com ↗
A similar reduction in exacerbations with FF/VI was seen in those patients on an ICS/long-acting beta2-agonist (LABA) at baseline (8.0%; 95% CI 0.11 to 15.4, p=0.047). |
| 2016-06-20 | GlaxoSmithKline | Results FULFIL study shows superiority of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in improving lung function and health-related quality of life in COPD patients gsk.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. |
| 2015-09-24 | GlaxoSmithKline | Results Regulatory update: GSK and Theravance announce intention to file Relvar® Ellipta® for COPD in Japan gsk.com ↗
The study which included 1620 patients with COPD, of whom 370 were from Japan, showed that patients who received FF/VI 100/25mcg achieved a statistically significant improvement in lung function (as measured by change from baseline in trough FEV1) compared with VI 25mcg at 12 weeks (p=0.001). |
| 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. |
| 2015-03-19 | GlaxoSmithKline | Regulatory GSK and Theravance announce outcome of US FDA Advisory Committee on BREO® ELLIPTA® in asthma gsk.com ↗
The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against). |
| 2014-09-08 | GlaxoSmithKline | Results GSK data presented at ERS demonstrate potential of blood eosinophil levels to help inform COPD treatment decisions gsk.com ↗ |
| 2014-08-20 | GlaxoSmithKline | Regulatory GSK receives FDA approval for Arnuity™ Ellipta® (fluticasone furoate) in the USA for the treatment of asthma gsk.com ↗
GlaxoSmithKline plc today announced that the Food and Drug Administration has approved Arnuity™ Ellipta® (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. |
| 2014-06-30 | GlaxoSmithKline | Regulatory GSK and Theravance announce submission to US regulatory authorities for fluticasone furoate/vilanterol in asthma gsk.com ↗ |
| 2013-12-06 | GlaxoSmithKline | Results GSK and Theravance announce positive results from pivotal phase III study for fluticasone furoate/vilanterol in asthma gsk.com ↗
GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced positive results from a phase III efficacy and safety study of fluticasone furoate “FF”/vilanterol “VI” designed to support a potential filing for an asthma indication for adults in the US. |
| 2013-11-18 | GlaxoSmithKline | Regulatory RELVAR® ELLIPTA® receives European marketing authorisation for the treatment of asthma and COPD gsk.com ↗ |
| 2013-10-23 | GlaxoSmithKline | Regulatory GSK announces US regulatory submission for fluticasone furoate monotherapy for asthma gsk.com ↗
The NDA has been submitted to the US Food and Drug Administration (FDA) for FF monotherapy (100mcg and 200mcg doses) as a once-daily inhaled dry powder maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. |
| 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). |
| 2013-07-12 | GlaxoSmithKline | Regulatory Regulatory update: fluticasone furoate/vilanterol submission in Japan gsk.com ↗
As a result, a decision has been taken to withdraw COPD from the current JNDA at this time. |
| 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. |
| 2011-06-02 | GlaxoSmithKline | Results GSK and Theravance announce results of two pivotal Phase III studies for Relovair in COPD gsk.com ↗ |
| 2010-09-21 | GlaxoSmithKline | Results GSK and Theravance announce combination ICS/LABA Phase II results in the Relovair™ development programme gsk.com ↗
The most common adverse events (FFVI; placebo) were nasopharyngitis (18%;15%), headache (15%; 5%), dizziness (5%; 5%) and candidiasis (8%;0%). |
| 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 39 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 167 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fluticasone furoate | “We present the protocol for the ongoing INTREPID (INvestigation of TRelegy Effectiveness: usual PractIce Design; ClinicalTrials.gov identifier: NCT03467425) study, a...” PMID 31720293 ↗ Nov 2019139“An Open Label, Part-randomised, Four-way Crossover, Single and Repeat Dose Study to Determine the Dose Proportionality and Absolute Bioavailability of Fluticasone Furoate (FF)...” NCT01669070 ↗ “The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal spray (FFNS), without the use of an antibiotic, in the treatment of adult and...” NCT01018030 ↗ “The study aim was to investigate the pharmacokinetics of single high doses and repeated therapeutic doses of fluticasone furoate (FF) and batefenterol (BAT; a bifunctional...” PMID 30070770 ↗ Aug 2018 “A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation...” NCT01706328 ↗ “A 12-week, Prospective, Open Label, Single Cohort Study to Evaluate the Real-world Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in a Single Inhaler...” NCT05535972 ↗ “Participants will inhale a LABA (vilanterol (25mcg)) + LAMA (umeclidinium (62.5mcg))+ Inhaled Corticosteroid (ICS; fluticasone furoate (100mcg)) medication once daily for 28+...” NCT06552364 ↗ “Effectiveness of Fluticasone Furoate/ Umeclidinium/ Vilanterol (FF/UMEC/VI) Using the Connected Inhaler System (CIS) as Compared With Fluticasone Proprionate/ Salmeterol...” NCT03376932 ↗ “pharmacokinetics of fluticasone furoate (FF), umeclidinium (UMEC), and vilanterol (VI) in patients with chronic obstructive pulmonary disease (COPD) when administered as a...” PMID 31321713 ↗ Jan 2020 “Subjects in group A (study) will be treated with Fluticasone Furoate nasal: (50 micrograms/spray) 100 micrograms (2 sprays) in each nostril twice daily plus oral montelukast...” NCT05381207 ↗ “A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic...” NCT03474081 ↗ |
| Known as | ALLERMIST | “FF is approved worldwide (including the US, EU and Japan) as an intranasal steroid for the treatment of allergic rhinitis (VERAMYST™ /AVAMYS™ /ALLERMIST™).” NCT01000597 ↗ |
| Known as | Avamys | “FF is approved worldwide (including the US, EU and Japan) as an intranasal steroid for the treatment of allergic rhinitis (VERAMYST™ /AVAMYS™ /ALLERMIST™).” NCT01000597 ↗2“AVAMYS (TM) (fluticasone furoate aqueous nasal spray 100mcg) has been shown having effects on nasal symptoms of seasonal and perennial allergic rhinitis” NCT01270958 ↗ “Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD” NCT04621513 ↗ |
| Known as | AVAMYS (TM) | “AVAMYS (TM) (fluticasone furoate aqueous nasal spray 100mcg) has been shown having effects on nasal symptoms of seasonal and perennial allergic rhinitis” NCT01270958 ↗ |
| Known as | FFNS | “The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal spray (FFNS), without the use of an antibiotic, in the treatment of adult and...” NCT01018030 ↗5“Fluticasone furoate nasal spray (FFNS) is a novel, enhanced-affinity intranasal corticosteroid administered for the management of allergic rhinitis (AR).” PMID 21888757 ↗ Aug 2011 “The effect of fluticasone furoate nasal spray (FFNS) on growth in prepubescent children has not been evaluated.” PMID 25017530 ↗ May 2014 “Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg” NCT02424539 ↗ “fluticasone furoate nasal spray \[FFNS\]” NCT00609674 ↗ |
| Known as | Fluticasone furoate nasal spray | “an intranasal corticosteroid (fluticasone furoate nasal spray” NCT00609674 ↗2“fluticasone furoate nasal spray 110ug, once daily” NCT01231464 ↗ “fluticasone furoate nasal spray” NCT00539006 ↗ |
| Known as | GW685698 | “A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)” NCT01551758 ↗5“fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler (NDPI)” NCT01395888 ↗ “Fluticasone furoate (FF, GW685698) is a novel once daily inhaled corticosteroid (ICS)” NCT01453023 ↗ “Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder” NCT02446418 ↗ “Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder” NCT01706198 ↗ “GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)” NCT01498679 ↗ |
| Known as | GW685698X | “GW685698X (fluticasone furoate) 100mcg Morning” NCT01499446 ↗ |
| Known as | VERAMYST | “FF is approved worldwide (including the US, EU and Japan) as an intranasal steroid for the treatment of allergic rhinitis (VERAMYST™ /AVAMYS™ /ALLERMIST™).” NCT01000597 ↗2“Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray” NCT01279057 ↗ “Fluticasone Furoate Nasal Spray (Veramyst)” NCT01076439 ↗ |
| Action | Activate | “GW685698X is a novel glucocorticoid receptor agonist” NCT00522678 ↗ |
| Modality | Other / unclassified | “intranasal steroid inhibits the nasal ocular reflex” PMID 23406601 ↗ Jan 2013 |
| Route | Intranasal | “Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg” NCT00103454 ↗ |