A Stratified, Randomized, Double-blind, Placebo-controlled, Parallel-group, 12 Week Trial Evaluating the Safety and Efficacy of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate DISKUS 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma

Not Applicable

• Conditions: -J459 Asthma, unspecified; Asthma, unspecified; J459

• Registration Number: PER-027-03
• Lead Sponsor: GLAXOSMITHKLINE PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-04-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Out-patients
Asthma diagnosis
Reversibility
Short-acting beta-agonist or asthma controlled medication use

Exclusion Criteria

Life-threatening asthma
Specified asthma medications
Chickenpox
Drug allergy
Respiratory infections
Tobacco use
Clinical laboratory abnormalities
Ophthalmologic conditions
Investigation medications
Affiliation with investigator site

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:PEF MP daily<br>Measure:Superior efficacy and comparable safety of the combination product fluticasone propionate / salmeterol DISKUS 100/50 mcg once a day compared to fluticasone propionate DISKUS 100 mcg once a day in pediatric patients with asthma aged between 4 and 11 years.<br>Timepoints:12 - 24 hours<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Adverse events, percentage of patients discontinued due to deterioration of asthma, results of clinical laboratory tests.<br>Measure:Superior efficacy and comparable safety of fluticasone propionate DISKUS 100 mcg once a day compared with placebo in pediatric patients with asthma aged 4-11 years.<br>Timepoints:week 2<br>