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Study HZA106829: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics

NCT01134042 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 587

Last updated 2017-01-11

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 each evening with fluticasone furoate inhalation powder administered alone once daily each evening 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 Furoate Inhalation Powder

Fluticasone furoate inhalation powder inhaled orally once daily for 24 weeks

DRUG

Fluticasone Propionate Inhalation Powder

Fluticasone propionate inhalation powder inhaled orally twice daily for 24 weeks

OTHER

Placebo Inhalation Powder 1

Placebo in novel dry powder inhaler once daily

OTHER

Placebo Inhalation Powder 2

Placebo in Diskus inhaler twice daily

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
2011-10-31
Completion
2011-10-31

Countries

  • United States
  • Germany
  • Japan
  • Poland
  • Romania
  • Russia

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 NCT01134042 on ClinicalTrials.gov