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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01181895

Run by

GlaxoSmithKline

People needed

348

Starts

2010-09-01

Expected to finish

2011-08-26

Last updated by the study team

2017-11-08

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Tallahassee, Florida, United States
• GSK Investigational Site — Lawrenceville, Georgia, United States
• GSK Investigational Site — Skillman, New Jersey, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Chester, South Carolina, United States
• GSK Investigational Site — Clinton, South Carolina, United States
• GSK Investigational Site — Orangeburg, South Carolina, United States
• GSK Investigational Site — Gauting, Bavaria, Germany
• GSK Investigational Site — Frankfurt am Main, Hesse, Germany
• GSK Investigational Site — Mainz, Rhineland-Palatinate, Germany
• GSK Investigational Site — Großhansdorf, Schleswig-Holstein, Germany
• GSK Investigational Site — Lima, Lima Province, Peru
• GSK Investigational Site — San Isidro, Lima region, Peru
• GSK Investigational Site — San Miguel, Lima region, Peru
• GSK Investigational Site — Callao, Lima, Peru
• GSK Investigational Site — Lima, Peru
• GSK Investigational Site — Chrzanów, Poland
• GSK Investigational Site — Krakow, Poland
• GSK Investigational Site — Krakow, Poland
• GSK Investigational Site — Krakow, Poland
• GSK Investigational Site — Lublin, Poland

Full record on ClinicalTrials.gov

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