Drugs / Fluticasone Furoate

Regulatory milestones approvals, filings & regulatory actions · 6 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
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

today
US approved 2007
EU approved 2008
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1
14
3
9
3
8
16
10
13
5
6
8
6
5
4
3
4
3
1
1
2
20032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 215 trials
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 No outcome recorded
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 No outcome recorded
Phase 2 NCT01957202 Oct 2013 → Feb 2014 allergic rhinitis GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT01808339 Mar 2013 → Mar 2014 asthma GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT01287065 Oct 2010 → Sep 2011 asthma GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT01018030 Jan → Jul 2010 sinusitis GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT00766090 Oct 2008 → Mar 2009 asthma GlaxoSmithKline Completed No outcome recorded
Phase 360 trials
Phase 3 NCT07223294 Apr 2026 respiratory system disorder Sandoz Withdrawn No outcome recorded
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 No outcome recorded
Phase 3 NCT03184987 Jun 2017 → Jun 2019 asthma GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT02924688 Oct 2016 → Feb 2019 asthma GlaxoSmithKline Completed No outcome recorded
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 No outcome recorded
Phase 3 NCT02446418 Jul 2015 → Jul 2017 asthma GlaxoSmithKline Completed No outcome recorded
Phase 426 trials
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
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 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
Also used as a comparator or background therapy in 39 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05381207 Comparator Oct 2022 → Oct 2024 allergic rhinitis Assiut University Unknown No outcome recorded
Phase 11 trial
Phase 1 NCT02218723 Comparator Oct → Dec 2014 asthma GlaxoSmithKline Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT05143502 Background Jan 2022 → Jan 2024 chronic rhinosinusitis Assiut University Unknown No outcome recorded
Phase 210 trials
Phase 2 NCT04072887 Background Sep 2019 → Oct 2021 chronic obstructive pulmonary disease Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT03622112 Comparator Jan → Sep 2019 asthma AstraZeneca Completed No outcome recorded
Phase 2 NCT03012061 Background Jan 2017 → May 2018 asthma GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT01573624 Comparator Apr 2012 → Feb 2013 asthma GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT01563029 Comparator Mar 2012 → Sep 2014 asthma GlaxoSmithKline Completed No outcome recorded
Phase 311 trials
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 413 trials
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 not applicable2 trials
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

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 167 sources stand behind the page.

FieldValueCited 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 2019
139

“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

fluticasone furoate 55 µg (formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water) once daily in...” NCT01562093

“All subjects received fluticasone furoate/vilanterol ELLIPTA dry-powder inhalers for maintenance and salbutamol/albuterol metered-dose inhalers for rescue, with a sensor...” PMID 33334936 Jun 2021

“A Relative Bioavailability Study to Compare the Pharmacokinetics of a Fixed Dose Combination of Fluticasone Furoate and Levocabastine With Levocabastine and Fluticasone Furoate Alone” NCT01962467

“A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)” NCT01551758

fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) improved lung function, symptoms and asthma control versus FF/VI in patients with inadequately controlled asthma.” PMID 34162298 Jul 2021

“Pharmacokinetic Profile of Four Formulations of Fluticasone Furoate (FF) Using Unit Dose Dry Powder Inhaler (UD-DPI) Compared With FF ELLIPTA® Presentation” NCT02218723

Fluticasone furoate will be given twice a day with two sprays (100 µg) for each nostril for 2 weeks, then continue for once a day with two sprays (100 µg).” NCT05276336

fluticasone furoate/GW642444M combination significantly increases the systemic effects and exposure to repeat dose fluticasone furoate and/or GW642444” NCT01165125

“OBJECTIVE: To compare the effects of intranasal fluticasone furoate (FF)/levocabastine (LEVO) fixed-dose combination (FDC) with each component alone” PMID 25900517 Aug 2015

“Fixed Combination Of Fluticasone Furoate Plus Vilanterol Administered Via Dry Powder Inhaler (DPI) (Relvar®) Plus Tiotropium Bromide (Spiriva®)” NCT02467452

“Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma” NCT03248128

“Although the safety of inhaled Fluticasone Furoate (FF) on the HPA axis of adults and adolescent asthmatic patients has been established” NCT02483975

“The objective of this study is to evaluate the safety of fluticasone furoate aqueous nasal spray 110mcg once daily in adults with PAR.” NCT01270958

“The investigational drug is a single Ellipta inhaler containing 200 ug fluticasone furoate, 62.5 ug umedlidinium and 25 ug vilanterol.” NCT04651777

“A combination of fluticasone furoate (FF) and umeclidinium (UMEC) has been considered for development for the treatment of asthma.” PMID 25700806 Feb 2015

Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.” NCT05757102

“Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Patients With Asthma” NCT03184987

“Dry white powder containing 100mcg of Fluticasone Furoate blended with lactose per blister was administered by DPI.” NCT01957163

“Dry white powder containing 100mcg of Fluticasone Furoate blended with lactose per blister was administered by DPI.” NCT02119286

“TRELEGY ELLIPTA (fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg inhalation powder)” NCT05292053

“two 1-year randomised, controlled trials of fluticasone furoate (FF)/vilanterol (VI) versus VI alone” PMID 27251682 Jun 2016

Fluticasone furoate is available as fluticasone furoate inhalation powder (100 mcg per blister)” NCT02164539

Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) With Multiple Inhaler Therapy” NCT03478696

Fluticasone Furoate /Umeclidinium Bromide/Vilanterol (100/62.5/25 Microgram [mcg])” NCT02837380

Fluticasone furoate inhalation powder blended with lactose, 100 mcg per blister” NCT01837316

“combination fluticasone furoate (FF)/vilanterol (VI) in Asian asthma patients.” PMID 25524507 Oct 2014

“Combination of fluticasone furoate, vilanterol and umeclidinium bromide” NCT04072887

“administration of fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg.” PMID 24200619 Nov 2013

Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg” NCT02424539

fluticasone furoate 200mcg/GW642444M 25mcg once daily for 7 days” NCT01266980

Fluticasone Furoate is a novel inhaled corticosteroid (ICS).” NCT01691547

Fluticasone Furoate (FF)/Umeclidinium(UMEC)/Vilanterol (VI)” NCT04923347

fluticasone furoate (FF; an inhaled corticosteroid [ICS])” PMID 25452139 Oct 2014

“Inhaled Fluticasone Furoate/GW642444M Combination” NCT01128595

“110mcg Fluticasone Furoate Nasal Spray” NCT00519636

fluticasone furoate 110 μg nasal spray” NCT00289198

Fluticasone Furoate Inhalation Powder” NCT01054885

fluticasone furoate (FF) nasal spray” NCT02397915

fluticasone furoate nasal spray” NCT00539006

Fluticasone Furoate (FF)” NCT01894386

Fluticasone furoateNCT03622112

NCT02712047

NCT01323621

NCT02502734

NCT00730756

NCT01686633

NCT01000597

NCT01165138

NCT02573870

NCT01630135

NCT01007253

NCT05299086

NCT01299558

NCT02991859

NCT00997620

NCT01498679

NCT05342558

NCT02731846

NCT01313676

NCT02064504

NCT01086384

NCT02094937

NCT00398476

NCT00435461

NCT01128569

NCT01691885

NCT01706198

NCT00609674

NCT01072149

NCT01453023

NCT03152149

NCT05651750

NCT00791973

NCT01013701

NCT01711463

NCT01342913

NCT00115622

NCT01957150

NCT02889809

NCT00603044

NCT00891436

NCT01231464

NCT07223294

NCT02345161

NCT01435902

NCT01436110

NCT01018186

NCT03363191

NCT01134042

NCT01323634

NCT05143502

NCT00502775

NCT01244984

NCT02446418

NCT01147848

NCT03673384

NCT01431950

NCT01499446

NCT01279057

NCT01192191

NCT03012061

NCT01318681

NCT02730351

NCT00473915

NCT01563029

NCT06077019

NCT01159912

NCT02164513

NCT02301975

NCT01209026

NCT01332292

NCT06372496

NCT02105974

NCT03949842

NCT00570492

NCT01622231

NCT07192016

NCT03898466

NCT01076439

NCT03739294

NCT01808339

NCT00584987

NCT03315000

NCT00682643

NCT01213849

NCT01436071

NCT01395888

NCT01336608

NCT06066606

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

NCT00519636

Known as fluticasone furoate nasal spray “an intranasal corticosteroid (fluticasone furoate nasal sprayNCT00609674
2

fluticasone furoate nasal spray 110ug, once daily” NCT01231464

fluticasone furoate nasal sprayNCT00539006

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
23

NCT00225823

NCT00766090

NCT00116883

NCT00363740

NCT00108914

NCT00107757

NCT00117325

NCT00103454

NCT00109486

NCT00603746

NCT00522678

NCT00538057

NCT00118729

NCT00118703

NCT00224523

NCT00398645

NCT00603382

NCT00419237

NCT00116818

NCT00972673

NCT00444509

NCT00603278

NCT00197262

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