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

NCT01181895 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2017-11-08

Study results available
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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.

Conditions

Interventions

DRUG

Vilanterol

Vilanterol inhalation powder inhaled orally once 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

DRUG

Placebo Inhalation Powder Diskus

Placebo inhalation powder inhaled orally twice daily for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-01
Primary Completion
2011-08-01
Completion
2011-08-26

Countries

  • United States
  • Germany
  • Peru
  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01181895 on ClinicalTrials.gov