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6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old

NCT01462344 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6250

Last updated 2018-08-06

Study results available
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Summary

The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

Conditions

Interventions

DRUG

ADVAIR 100/50mcg

fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months

DRUG

ADVAIR 250/50mcg

fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months

DRUG

FLOVENT 100mcg

fluticasone propionate (100) twice daily (AM and PM) for 6 months

DRUG

FLOVENT 250mcg

fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months

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
2011-11-17
Primary Completion
2015-11-01
Completion
2015-11-03

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Croatia
  • Czechia
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom

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 NCT01462344 on ClinicalTrials.gov