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

NCT ID: NCT01181895

Last Updated: 2017-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-01

Study Completion Date

2011-08-26

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vilanterol

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

Group Type EXPERIMENTAL

Vilanterol

Intervention Type DRUG

Vilanterol inhalation powder inhaled orally once daily for 12 weeks

Placebo Inhalation Powder Diskus

Intervention Type DRUG

Placebo inhalation powder inhaled orally twice daily for 12 weeks

Salmeterol

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

Group Type ACTIVE_COMPARATOR

Salmeterol Inhalation Powder

Intervention Type DRUG

Salmeterol inhalation powder inhaled orally twice daily for 12 weeks

Placebo Inhalation Powder NDPI

Intervention Type DRUG

Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo Inhalation Powder NDPI

Intervention Type DRUG

Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler

Placebo Inhalation Powder Diskus

Intervention Type DRUG

Placebo inhalation powder inhaled orally twice daily for 12 weeks

Interventions

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Vilanterol

Vilanterol inhalation powder inhaled orally once daily for 12 weeks

Intervention Type DRUG

Salmeterol Inhalation Powder

Salmeterol inhalation powder inhaled orally twice daily for 12 weeks

Intervention Type DRUG

Placebo Inhalation Powder NDPI

Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler

Intervention Type DRUG

Placebo Inhalation Powder Diskus

Placebo inhalation powder inhaled orally twice daily for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Huntington Beach, California, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

Site Status

GSK Investigational Site

Tallahassee, Florida, United States

Site Status

GSK Investigational Site

Lawrenceville, Georgia, United States

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GSK Investigational Site

Skillman, New Jersey, United States

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GSK Investigational Site

Raleigh, North Carolina, United States

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GSK Investigational Site

Cincinnati, Ohio, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, United States

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GSK Investigational Site

Chester, South Carolina, United States

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Clinton, South Carolina, United States

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Orangeburg, South Carolina, United States

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GSK Investigational Site

Gauting, Bavaria, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, Germany

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GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

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GSK Investigational Site

Großhansdorf, Schleswig-Holstein, Germany

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GSK Investigational Site

Lima, Lima Province, Peru

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GSK Investigational Site

San Isidro, Lima region, Peru

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GSK Investigational Site

San Miguel, Lima region, Peru

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GSK Investigational Site

Callao, Lima, Peru

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GSK Investigational Site

Lima, , Peru

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GSK Investigational Site

Chrzanów, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

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GSK Investigational Site

Krakow, , Poland

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GSK Investigational Site

Krakow, , Poland

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GSK Investigational Site

Lublin, , Poland

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GSK Investigational Site

Dnipropetrovsk, , Ukraine

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GSK Investigational Site

Dnipropetrovsk, , Ukraine

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GSK Investigational Site

Donetsk, , Ukraine

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GSK Investigational Site

Ivano-Frankivsk, , Ukraine

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GSK Investigational Site

Kharkiv, , Ukraine

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GSK Investigational Site

Kharkiv, , Ukraine

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GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Simferopol, , Ukraine

Site Status

GSK Investigational Site

Yalta, , Ukraine

Site Status

Countries

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United States Germany Peru Poland Ukraine

References

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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.

Reference Type DERIVED
PMID: 24928338 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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112060

Identifier Type: -

Identifier Source: org_study_id