HZA106827: A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Parallel Group Multicentre Study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder 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
- 612
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder both administered once daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 12 week treatment period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Outpatients at least 12 years of age
- •Male and female; female subjects of childbearing potential must be willing to use birth control
- •Pre-bronchodilator FEV1 of 40-90% predicted normal
- •Reversibility FEV1 of at least 12% and 200mL
- •Current asthma therapy includes inhaled corticosteroid use for at least 12 weeks prior to first visit
Exclusion Criteria
- •History of life-threatening asthma during last 10 years
- •Respiratory infection or oral candidiasis
- •Asthma exacerbation requiring oral corticosteroids or that required overnight hospitalisation requiring additional asthma treatment
- •Uncontrolled disease or clinical abnormality
- •Allergies to study drugs or the excipients
- •Taking another investigational medication or prohibited medication
- •Night shift workers
- •Current smokers or subjects with a smoking history of at least 10 pack years
Arms & Interventions
Fluticasone furoate/Vilanterol (GW642444)
Fluticasone furoate/Vilanterol inhalation powder once daily for 12 weeks
Intervention: Fluticasone furoate/Vilanterol Inhalation Powder
Fluticasone Furoate
Fluticasone furoate inhalation powder once daily for 12 weeks
Intervention: Fluticasone Furoate Inhalation Powder
Placebo
Placebo inhalation powder once daily for 12 weeks
Intervention: Placebo Inhaltion Powder
Outcomes
Primary Outcomes
Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12
Time Frame: Baseline and Week 12
Pulmonary function was measured by FEV1, 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) FEV1measurement 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 through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the Week 12 value minus the Baseline value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, region, 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-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing m
Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12
Time Frame: Baseline and Week 12
Pulmonary function was measured by FEV1, 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 12 clinic visits. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing at Baseline and within 5 minutes prior to dosing at Week 12) and 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 12 FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.
Secondary Outcomes
- Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period(Baseline and Week 12)
- Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period(Baseline and Week 12)
- Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12/Early Withdrawal(Baseline and Week 12/Early Withdrawal)
- Number of Participants Who Withdrew Due to Lack of Efficacy During the 12-week Treatment Period(From the first dose of the study medication up to Week 12/Early Withdrawal)
- Serial FEV1 Over 0-1 Hour Post-dose at Randomization(Randomization)