Phase 3
Completed N=586
Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics
Source: ClinicalTrials.gov NCT01134042 ↗Enrolled (actual)
586
Serious AEs
1.5%
Results posted
Aug 2013
Primary outcomePrimary: 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 — 0.201; 0.394; 0.183 Liters — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0.201; 0.394; 0.183 | <0.001 sig |
| PRIMARY Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 |
0.328; 0.464; 0.258 | 0.048 sig |
| SECONDARY Change From Baseline in the Percentage of Rescue-free and Symptom-free 24-hour Periods at the End of the 24-week Treatment Period |
26.6; 38.2; 31.9; 21.0; 29.3; 24.5 | — |
| SECONDARY Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24/Early Withdrawal |
0.66; 0.74; 0.74; 0.88; 0.93; 0.90 | — |
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
Data sourced from ClinicalTrials.gov (NCT01134042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.