Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications

Phase 3

Completed

• Conditions: Asthma

• Registration Number: NCT00158834
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when compared to treatment based on cumulative symptom scores and bronchial hyperresponsiveness (PD20 methacholine).

Detailed Description

Not available

Study Timeline

• Study Start: 1999-11
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-12
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-09
• Last Update Posted: 2008-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Asthma symptom free days during the last 12 weeks of the treatment period.

Secondary Outcome Measures

Name	Time	Method
Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study.

Trial Locations

Locations (1)

GSK Investigational Site; 🇳🇱 Zwolle, Netherlands