Phase 3
Completed N=1,564
HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents
Source: ClinicalTrials.gov NCT01147848 ↗Enrolled (actual)
1,564
Serious AEs
1.1%
Results posted
Sep 2013
Primary outcomePrimary: Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 — 0.341; 0.377 Liters — p=0.162
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 |
0.341; 0.377 | 0.162 |
| SECONDARY Serial FEV1 (0-24 Hours) |
0.304; 0.323; 0.320; 0.339; 0.323; 0.354 | — |
| SECONDARY Number of Participants With the Indicated Time to Onset of Bronchodilator Effect at Day 1 |
100; 85; 41; 51; 40; 55 | — |
| SECONDARY Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours Post First Dose (at Randomization) |
0.316; 0.346 | — |
| SECONDARY Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours at Day 168 |
0.360; 0.394 | — |
| SECONDARY Number of Participants Obtaining a >=12% and >=200 mL Increase From Baseline in FEV1 |
199; 178; 181; 176 | — |
| SECONDARY Change From Baseline in Trough FEV1 at Day 168 |
0.281; 0.300 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of asthma
- Reversibility of at least 12% and at least 200mLs within 10-40 minutes following 2-4 inhalations of albuterol
- FEV1 of 40-85% predicted normal
- Currently using inhaled corticosteroid therapy
Exclusion Criteria
- History of life-threatening asthma within previous 5 years (requiring intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures)
- Respiratory infection or oral candidiasis
- Asthma exacerbation requiring oral corticosteroids or that resulted in overnight hospitalisation requiring additional asthma treatment
- Uncontrolled disease or clinical abnormality
- Allergies
- Taking another investigational medication or prohibited medication
- Night shift workers
- Current smokers or subjects with smoking history of at least 10 pack years
Data sourced from ClinicalTrials.gov (NCT01147848). 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.