HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents
NCT01147848 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 810
Last updated 2017-01-18
Summary
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.
Conditions
Interventions
- DRUG
-
Fluticasone furoate/Vilanterol Inhalation Powder
Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 24 weeks
- DRUG
-
Fluticasone propionate/salmeterol Inhalation Powder
Fluticasone propionate/salmeterol Inhalation Powder inhaled orally twice daily for 24 weeks
- DRUG
-
Placebo (1)
Inhalation powder inhaled orally once daily for 24 weeks
- DRUG
-
Placebo (2)
Inhalation powder inhaled orally twice daily for 24 weeks
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2011-07-31
- Completion
- 2011-07-31
Countries
- United States
- Argentina
- Chile
- Netherlands
- Philippines
- South Korea
Study Locations
More Related Trials
-
Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response
NCT01128569 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry
NCT01498653 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents
NCT01159912 ·Status: COMPLETED ·Phase: PHASE3
-
A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma
NCT00441441 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise
NCT01435902 ·Status: WITHDRAWN ·Phase: PHASE3
-
Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry.
NCT01498679 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma
NCT03248128 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler
NCT02980133 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma
NCT02446418 ·Status: COMPLETED ·Phase: PHASE3
-
Fluticasone Furoate/GW642444 Inhalation Powder Long-Term Safety Study
NCT01018186 ·Status: COMPLETED ·Phase: PHASE3
-
The Efficacy of Fluticasone Furoate/Vilanterol Versus (vs) Fluticasone Furoate on Asthma
NCT03363191 ·Status: WITHDRAWN ·Phase: PHASE4
-
Inhaled Fluticasone Furoate/Vilanterol Safety and Tolerability, PK and PD Study
NCT01453023 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
NCT01147744 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Moderate-Dose ICS Therapy.
NCT00603746 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study of the Effects of Inhaled Fluticasone Furoate/GW642444 on the Hypothalamic-Pituitary-Adrenal (HPA) Axis
NCT01086410 ·Status: COMPLETED ·Phase: PHASE3
-
Randomised Study Comparing the Effects of Inhaled FF/GW642444M Combination, FF and GW642444M on an Allergen Induced Asthmatic Response
NCT01128595 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Non-steroidal Therapy.
NCT00603382 ·Status: COMPLETED ·Phase: PHASE2
-
A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma
NCT06664619 ·Status: RECRUITING ·Phase: PHASE3
-
Efficacy and Safety Study of FP MDPI Compared With FS MDPI in Adolescent and Adult Patients With Persistent Asthma
NCT02141854 ·Status: COMPLETED ·Phase: PHASE3
-
Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma
NCT01181895 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma
NCT00393991 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma
NCT07223294 ·Status: WITHDRAWN ·Phase: PHASE3
-
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma
NCT00394199 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Low-Dose ICS Therapy.
NCT00603278 ·Status: COMPLETED ·Phase: PHASE2
-
A Dose-ranging Study of Fluticasone Furoate (FF)
NCT01563029 ·Status: COMPLETED ·Phase: PHASE2