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A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma

NCT00441441 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2016-12-16

Study results available
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Summary

This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.

Conditions

Interventions

DRUG

fluticasone propionate

fluticasone propionate 100mcg HFA

DRUG

fluticasone propionate/salmeterol

fluticasone propionate/salmeterol 100/50mcg HFA

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States
  • Australia
  • Canada
  • Chile
  • Costa Rica
  • Germany
  • Latvia
  • Lithuania
  • Mexico
  • Peru
  • Poland
  • Russia
  • Spain

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 NCT00441441 on ClinicalTrials.gov