HZA106829: A Randomised, Double-blind, Parallel Group, Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder, Fluticasone Furoate Inhalation Powder Alone, and Fluticasone Propionate Alone in the Treatment of Persistent Asthma in Adults and Adolescents
Overview
- Phase
- Phase 3
- Intervention
- Fluticasone Furoate/Vilanterol Inhalation Powder
- Conditions
- Asthma
- Sponsor
- GlaxoSmithKline
- Enrollment
- 587
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Outpatient at least 12 years of age
- •Both genders; females of childbearing potential must be willing to use birth control method
- •Pre-bronchodilator FEV1 of 40-90% predicted
- •Reversibility FEV1 of at least 12% and 200mls
- •Current asthma therapy that includes an inhaled corticosteroid for at least 12 weeks prior to first visit
Exclusion Criteria
- •History of life-threatening asthma
- •Respiratory infection or oral candidiasis
- •Asthma exacerbation within 12 weeks
- •Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
- •Allergies to study drugs, study drugs' excipients, medications related to study drugs
- •Taking another investigational medication or medication prohibited for use during this study
Arms & Interventions
Fluticasone Furoate/Vilanterol
Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks
Intervention: Fluticasone Furoate/Vilanterol Inhalation Powder
Fluticasone Furoate/Vilanterol
Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks
Intervention: Placebo Inhalation Powder 2
Fluticasone Furoate
Fluticasone furoate inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks
Intervention: Fluticasone Furoate Inhalation Powder
Fluticasone Furoate
Fluticasone furoate inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks
Intervention: Placebo Inhalation Powder 2
Fluticasone Propionate
Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 24 weeks
Intervention: Fluticasone Propionate Inhalation Powder
Fluticasone Propionate
Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 24 weeks
Intervention: Placebo Inhalation Powder 1
Outcomes
Primary Outcomes
Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period
Time Frame: Baseline and Week 24
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit while still on treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline (BL) through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. BL was the pre-dose value obtained at Visit 3. Change from BL was calculated as the Week 24 value minus the Baseline value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of BL trough FEV1, country, sex, age, and treatment group.The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24
Time Frame: Baseline and Week 24
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 24 clinic visits. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 5 minutes prior to dosing) and the post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 24 FEV1 value minus the Baseline value.
Secondary Outcomes
- Change From Baseline in the Percentage of Rescue-free and Symptom-free 24-hour Periods at the End of the 24-week Treatment Period(Baseline and Week 24)
- Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24/Early Withdrawal(Baseline, Week 12, and Week 24/Early Withdrawal)