Phase 3
Completed N=347
Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma
Source: ClinicalTrials.gov NCT01181895 ↗Enrolled (actual)
347
Serious AEs
0.6%
Results posted
Aug 2013
Primary outcomePrimary: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 — 0.289; 0.359; 0.283 Liters — p=0.244
Summary
The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 |
0.289; 0.359; 0.283 | 0.244 |
| SECONDARY Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period |
14.6; 21.7; 22.9 | — |
| SECONDARY Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period |
12.7; 19.4; 19.5 | — |
| SECONDARY Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points |
0.302; 0.272; 0.233; 0.313; 0.301; 0.214 | — |
| SECONDARY Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) PM (Evening) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period |
11.0; 24.9; 18.8 | — |
| SECONDARY Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period |
14.2; 28.0; 23.6 | — |
| SECONDARY Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours) |
23; 33; 18; 2; 11; 11 | — |
| SECONDARY Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12 |
25; 37; 34; 35; 43; 34 | — |
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
- Clinical diagnosis of asthma for ≥12 weeks
- Best pre-bronchodilator FEV1 of 40%-90% predicted
- Reversibility of FEV1 of at least 12% and 200mls
- Current asthma therapy that include an inhaled corticosteroid for at least 12 weeks prior to 1st visit
- Ability to use replace current short-acting rescue treatment with albuterol and ability to withhold albuterol use for at least 6 hours prior to study visits
Exclusion Criteria
- History of life-threatening asthma
- Respiratory infection within last 4 weeks leading to change in asthma management
- Asthma exacerbation within last 3 months
- Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drugs' excipients, or medications related to study drugs
- Taking another investigational medication or medication prohibited for use during the study.
- Previous participation in a vilanterol (GW642444) study
Data sourced from ClinicalTrials.gov (NCT01181895). 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.