- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01181895
Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma
October 9, 2017 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
348
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bayern
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Gauting, Bayern, Germany, 82131
- GSK Investigational Site
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Hessen
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Frankfurt, Hessen, Germany, 60596
- GSK Investigational Site
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Germany, 55131
- GSK Investigational Site
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Schleswig-Holstein
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Grosshansdorf, Schleswig-Holstein, Germany, 22927
- GSK Investigational Site
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Lima, Peru, Lima 27
- GSK Investigational Site
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Lima
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Callao, Lima, Peru, Callao 2
- GSK Investigational Site
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Lima 27, Lima, Peru, Lima 27
- GSK Investigational Site
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San Isidro, Lima, Peru, Lima 27
- GSK Investigational Site
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San Miguel, Lima, Peru, Lima 32
- GSK Investigational Site
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Chrzanow, Poland, 32-500
- GSK Investigational Site
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Krakow, Poland, 31-024
- GSK Investigational Site
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Krakow, Poland, 31-455
- GSK Investigational Site
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Krakow, Poland, 30-901
- GSK Investigational Site
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Lublin, Poland, 20-552
- GSK Investigational Site
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Dnipropetrovsk, Ukraine, 49074
- GSK Investigational Site
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Dnipropetrovsk, Ukraine, 49027
- GSK Investigational Site
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Donetsk, Ukraine, 83099
- GSK Investigational Site
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Ivano-Frankivsk, Ukraine, 76018
- GSK Investigational Site
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Kharkiv, Ukraine, 61124
- GSK Investigational Site
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Kharkiv, Ukraine, 61037
- GSK Investigational Site
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Kyiv, Ukraine, 03680
- GSK Investigational Site
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Simferopol, Ukraine, 95043
- GSK Investigational Site
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Yalta, Ukraine, 98603
- GSK Investigational Site
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California
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Huntington Beach, California, United States, 92647
- GSK Investigational Site
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Florida
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Orlando, Florida, United States, 32822
- GSK Investigational Site
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Tallahassee, Florida, United States, 32308
- GSK Investigational Site
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Georgia
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Lawrenceville, Georgia, United States, 30046
- GSK Investigational Site
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New Jersey
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Skillman, New Jersey, United States, 08558
- GSK Investigational Site
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North Carolina
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Raleigh, North Carolina, United States, 27607
- GSK Investigational Site
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Ohio
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Cincinnati, Ohio, United States, 45231
- GSK Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- GSK Investigational Site
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South Carolina
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Chester, South Carolina, United States, 29706
- GSK Investigational Site
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Clinton, South Carolina, United States, 29325
- GSK Investigational Site
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Orangeburg, South Carolina, United States, 29118
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Vilanterol
Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
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Vilanterol inhalation powder inhaled orally once daily for 12 weeks
Placebo inhalation powder inhaled orally twice daily for 12 weeks
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Active Comparator: Salmeterol
Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks
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Salmeterol inhalation powder inhaled orally twice daily for 12 weeks
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
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Placebo Comparator: Placebo
Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
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Placebo inhalation powder inhaled orally twice daily for 12 weeks
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12
Time Frame: Baseline and Week 12
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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.
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Baseline and Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period
Time Frame: Baseline and Weeks 1-12
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The time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period.
The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization).
Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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Baseline and Weeks 1-12
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Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period
Time Frame: Baseline and Weeks 1-12
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Participants who were symptom free for 24-hour periods during the12-week treatment period were assessed.
The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization).
Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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Baseline and Weeks 1-12
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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
Time Frame: Baseline and Week 12
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FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second.
The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12).
The Baseline value was the Day 1 pre-dose FEV1 measurement.
Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value.
Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.
Analysis was performed separately for each planned time point.
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Baseline and Week 12
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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
Time Frame: Baseline and Weeks 1-12
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PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated.
Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug.
The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization.
Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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Baseline and Weeks 1-12
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Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period
Time Frame: Baseline and Weeks 1-12
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PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated.
Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug.
The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization.
Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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Baseline and Weeks 1-12
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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)
Time Frame: Day 1 and Week 12
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The number of participants with a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a >=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points.
Participants who did not achieve a >=12% and >=200 mL increase from Baseline in FEV1 over this time period were considered censored.
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Day 1 and Week 12
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Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Time Frame: Week 4 and Week 12
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At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often.
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Week 4 and Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 26, 2011
Study Registration Dates
First Submitted
July 15, 2010
First Submitted That Met QC Criteria
August 12, 2010
First Posted (Estimate)
August 13, 2010
Study Record Updates
Last Update Posted (Actual)
November 8, 2017
Last Update Submitted That Met QC Criteria
October 9, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Salmeterol Xinafoate
Other Study ID Numbers
- 112060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Clinical Study Report
Information identifier: 112060Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 112060Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 112060Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 112060Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 112060Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 112060Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 112060Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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