Phase 3
Completed N=609
Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics
Source: ClinicalTrials.gov NCT01165138 ↗Enrolled (actual)
609
Serious AEs
0.2%
Results posted
Jul 2013
Primary outcomePrimary: Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12 — 0.196; 0.332; 0.368 Liters — p=0.002
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12 |
0.196; 0.332; 0.368 | 0.002 sig |
| PRIMARY Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12 |
0.212; 0.398; 0.513 | 0.003 sig |
| SECONDARY Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period |
17.8; 26.5; 37.1 | — |
| SECONDARY Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period |
14.6; 20.4; 32.5 | — |
| SECONDARY Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12/Early Withdrawal |
0.61; 0.76; 0.91 | — |
| SECONDARY Number of Participants Who Withdrew Due to Lack of Efficacy During the 12-week Treatment Period |
32; 6; 7 | — |
| SECONDARY Serial FEV1 Over 0-1 Hour Post-dose at Randomization |
2.489; 2.493; 2.484; 2.491; 2.529; 2.566 | — |
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
Data sourced from ClinicalTrials.gov (NCT01165138). 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.