Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma
A Randomized, Double-blind, Double-dummy, Parallel-group, Placebo Controlled (on Inhaled Corticosteroid Medication), Multicenter Study to Evaluate the Efficacy and Safety of Vilanterol Inhalation Powder (GW642444) and Salmeterol, Compared With Placebo in the Treatment of Persistent Asthma in Adults and Adolescents Uncontrolled on Inhaled Corticosteroids
1 other identifier
interventional
348
5 countries
34
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Sep 2010
Shorter than P25 for phase_3 asthma
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2010
CompletedFirst Posted
Study publicly available on registry
August 13, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2011
CompletedResults Posted
Study results publicly available
August 26, 2013
CompletedNovember 8, 2017
October 1, 2017
11 months
July 15, 2010
June 6, 2013
October 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.
Baseline and Week 12
Secondary Outcomes (7)
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period
Baseline and Weeks 1-12
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period
Baseline and Weeks 1-12
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
Baseline and Week 12
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
Baseline and Weeks 1-12
Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period
Baseline and Weeks 1-12
- +2 more secondary outcomes
Study Arms (3)
Vilanterol
EXPERIMENTALVilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
Salmeterol
ACTIVE COMPARATORPlacebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks
Placebo
PLACEBO COMPARATORPlacebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
Interventions
Salmeterol inhalation powder inhaled orally twice daily for 12 weeks
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
Placebo inhalation powder inhaled orally twice daily for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (34)
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Orlando, Florida, 32822, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Lawrenceville, Georgia, 30046, United States
GSK Investigational Site
Skillman, New Jersey, 08558, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Chester, South Carolina, 29706, United States
GSK Investigational Site
Clinton, South Carolina, 29325, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Gauting, Bavaria, 82131, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927, Germany
GSK Investigational Site
Lima, Lima Province, Lima 27, Peru
GSK Investigational Site
San Isidro, Lima region, Lima 27, Peru
GSK Investigational Site
San Miguel, Lima region, Lima 32, Peru
GSK Investigational Site
Callao, Lima, Callao 2, Peru
GSK Investigational Site
Lima, Lima 27, Peru
GSK Investigational Site
Chrzanów, 32-500, Poland
GSK Investigational Site
Krakow, 30-901, Poland
GSK Investigational Site
Krakow, 31-024, Poland
GSK Investigational Site
Krakow, 31-455, Poland
GSK Investigational Site
Lublin, 20-552, Poland
GSK Investigational Site
Dnipropetrovsk, 49027, Ukraine
GSK Investigational Site
Dnipropetrovsk, 49074, Ukraine
GSK Investigational Site
Donetsk, 83099, Ukraine
GSK Investigational Site
Ivano-Frankivsk, 76018, Ukraine
GSK Investigational Site
Kharkiv, 61037, Ukraine
GSK Investigational Site
Kharkiv, 61124, Ukraine
GSK Investigational Site
Kyiv, 03680, Ukraine
GSK Investigational Site
Simferopol, 95043, Ukraine
GSK Investigational Site
Yalta, 98603, Ukraine
Related Publications (1)
Lotvall J, Bateman ED, Busse WW, O'Byrne PM, Woodcock A, Toler WT, Jacques L, Goldfrad C, Bleecker ER. Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids. J Negat Results Biomed. 2014 Jun 13;13(1):9. doi: 10.1186/1477-5751-13-9.
PMID: 24928338DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2010
First Posted
August 13, 2010
Study Start
September 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 26, 2011
Last Updated
November 8, 2017
Results First Posted
August 26, 2013
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.