Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma

• ClinicalTrials.gov Identifier: NCT01181895
• Recruitment Status: Completed
• First Posted: August 13, 2010
• Results First Posted: August 26, 2013
• Last Update Posted: November 8, 2017
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Vilanterol; Drug: Salmeterol Inhalation Powder; Drug: Placebo Inhalation Powder NDPI; Drug: Placebo Inhalation Powder Diskus	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 348 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: September 1, 2010
• Actual Primary Completion Date: August 1, 2011
• Actual Study Completion Date: August 26, 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vilanterol; Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks	Drug: Vilanterol; Vilanterol inhalation powder inhaled orally once daily for 12 weeks; Drug: Placebo Inhalation Powder Diskus; Placebo inhalation powder inhaled orally twice daily for 12 weeks
Active Comparator: Salmeterol; Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks	Drug: Salmeterol Inhalation Powder; Salmeterol inhalation powder inhaled orally twice daily for 12 weeks; Drug: Placebo Inhalation Powder NDPI; Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
Placebo Comparator: Placebo; Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks	Drug: Placebo Inhalation Powder NDPI; Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler; Drug: Placebo Inhalation Powder Diskus; Placebo inhalation powder inhaled orally twice daily for 12 weeks

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.

Secondary Outcome Measures :

1. 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 ]
   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.
2. 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 ]
   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.
3. 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 ]
   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.
4. 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 ]
   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.
5. Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period [ Time Frame: Baseline and Weeks 1-12 ]
   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.
6. 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 ]
   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.
7. 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

GSK Investigational Site

Huntington Beach, California, United States, 92647

United States, Florida

GSK Investigational Site

Orlando, Florida, United States, 32822

GSK Investigational Site

Tallahassee, Florida, United States, 32308

United States, Georgia

GSK Investigational Site

Lawrenceville, Georgia, United States, 30046

United States, New Jersey

GSK Investigational Site

Skillman, New Jersey, United States, 08558

United States, North Carolina

GSK Investigational Site

Raleigh, North Carolina, United States, 27607

United States, Ohio

GSK Investigational Site

Cincinnati, Ohio, United States, 45231

United States, Oklahoma

GSK Investigational Site

Oklahoma City, Oklahoma, United States, 73103

United States, South Carolina

GSK Investigational Site

Chester, South Carolina, United States, 29706

GSK Investigational Site

Clinton, South Carolina, United States, 29325

GSK Investigational Site

Orangeburg, South Carolina, United States, 29118

Germany

GSK Investigational Site

Gauting, Bayern, Germany, 82131

GSK Investigational Site

Frankfurt, Hessen, Germany, 60596

GSK Investigational Site

Mainz, Rheinland-Pfalz, Germany, 55131

GSK Investigational Site

Grosshansdorf, Schleswig-Holstein, Germany, 22927

Peru

GSK Investigational Site

Callao, Lima, Peru, Callao 2

GSK Investigational Site

Lima 27, Lima, Peru, Lima 27

GSK Investigational Site

San Isidro, Lima, Peru, Lima 27

GSK Investigational Site

San Miguel, Lima, Peru, Lima 32

GSK Investigational Site

Lima, Peru, Lima 27

Poland

GSK Investigational Site

Chrzanow, Poland, 32-500

GSK Investigational Site

Krakow, Poland, 30-901

GSK Investigational Site

Krakow, Poland, 31-024

GSK Investigational Site

Krakow, Poland, 31-455

GSK Investigational Site

Lublin, Poland, 20-552

Ukraine

GSK Investigational Site

Dnipropetrovsk, Ukraine, 49027

GSK Investigational Site

Dnipropetrovsk, Ukraine, 49074

GSK Investigational Site

Donetsk, Ukraine, 83099

GSK Investigational Site

Ivano-Frankivsk, Ukraine, 76018

GSK Investigational Site

Kharkiv, Ukraine, 61037

GSK Investigational Site

Kharkiv, Ukraine, 61124

GSK Investigational Site

Kyiv, Ukraine, 03680

GSK Investigational Site

Simferopol, Ukraine, 95043

GSK Investigational Site

Yalta, Ukraine, 98603

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Clinical Study Report 

Identifier: 112060
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 112060
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 112060
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 112060
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 112060
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 112060
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 112060
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lötvall 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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01181895
• Other Study ID Numbers: 112060
• First Posted: August 13, 2010
• Results First Posted: August 26, 2013
• Last Update Posted: November 8, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.

Keywords provided by GlaxoSmithKline:

asthma

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Salmeterol Xinafoate; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action