HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents

NCT01147848 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 810

Last updated 2017-01-18

Study results available
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Summary

The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.

Conditions

Interventions

DRUG

Fluticasone furoate/Vilanterol Inhalation Powder

Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 24 weeks

DRUG

Fluticasone propionate/salmeterol Inhalation Powder

Fluticasone propionate/salmeterol Inhalation Powder inhaled orally twice daily for 24 weeks

DRUG

Placebo (1)

Inhalation powder inhaled orally once daily for 24 weeks

DRUG

Placebo (2)

Inhalation powder inhaled orally twice daily for 24 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
2010-06-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Argentina
  • Chile
  • Netherlands
  • Philippines
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT01147848 on ClinicalTrials.gov