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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vilanterol
Salmeterol Inhalation Powder
Placebo Inhalation Powder NDPI
Placebo Inhalation Powder Diskus
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Vilanterol

Salmeterol

Placebo

Arm Description

Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks

Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks

Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period
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.
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period
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.
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
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.
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
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.
Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period
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.
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)
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.
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of 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.

Full Information

First Posted
July 15, 2010
Last Updated
October 9, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01181895
Brief Title
Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma
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 Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2010 (undefined)
Primary Completion Date
August 1, 2011 (Actual)
Study Completion Date
August 26, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
348 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vilanterol
Arm Type
Experimental
Arm Description
Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
Arm Title
Salmeterol
Arm Type
Active Comparator
Arm Description
Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vilanterol
Intervention Description
Vilanterol inhalation powder inhaled orally once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Salmeterol Inhalation Powder
Intervention Description
Salmeterol inhalation powder inhaled orally twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo Inhalation Powder NDPI
Intervention Description
Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
Intervention Type
Drug
Intervention Name(s)
Placebo Inhalation Powder Diskus
Intervention Description
Placebo inhalation powder inhaled orally twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12
Description
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.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period
Description
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.
Time Frame
Baseline and Weeks 1-12
Title
Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period
Description
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.
Time Frame
Baseline and Weeks 1-12
Title
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
Description
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.
Time Frame
Baseline and Week 12
Title
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
Description
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.
Time Frame
Baseline and Weeks 1-12
Title
Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period
Description
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.
Time Frame
Baseline and Weeks 1-12
Title
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)
Description
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.
Time Frame
Day 1 and Week 12
Title
Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12
Description
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.
Time Frame
Week 4 and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32822
Country
United States
Facility Name
GSK Investigational Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
GSK Investigational Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
GSK Investigational Site
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
GSK Investigational Site
City
Chester
State/Province
South Carolina
ZIP/Postal Code
29706
Country
United States
Facility Name
GSK Investigational Site
City
Clinton
State/Province
South Carolina
ZIP/Postal Code
29325
Country
United States
Facility Name
GSK Investigational Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
GSK Investigational Site
City
Gauting
State/Province
Bayern
ZIP/Postal Code
82131
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
GSK Investigational Site
City
Grosshansdorf
State/Province
Schleswig-Holstein
ZIP/Postal Code
22927
Country
Germany
Facility Name
GSK Investigational Site
City
Callao
State/Province
Lima
ZIP/Postal Code
Callao 2
Country
Peru
Facility Name
GSK Investigational Site
City
Lima 27
State/Province
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
GSK Investigational Site
City
San Isidro
State/Province
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
GSK Investigational Site
City
San Miguel
State/Province
Lima
ZIP/Postal Code
Lima 32
Country
Peru
Facility Name
GSK Investigational Site
City
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
GSK Investigational Site
City
Chrzanow
ZIP/Postal Code
32-500
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
30-901
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-024
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-455
Country
Poland
Facility Name
GSK Investigational Site
City
Lublin
ZIP/Postal Code
20-552
Country
Poland
Facility Name
GSK Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
GSK Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
GSK Investigational Site
City
Donetsk
ZIP/Postal Code
83099
Country
Ukraine
Facility Name
GSK Investigational Site
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
GSK Investigational Site
City
Simferopol
ZIP/Postal Code
95043
Country
Ukraine
Facility Name
GSK Investigational Site
City
Yalta
ZIP/Postal Code
98603
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
24928338
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112060
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112060
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112060
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112060
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112060
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112060
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112060
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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