Advair Pediatric Once-Daily

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: FSC 100/50mcg; Drug: FP 100mcg; Drug: Placebo

• Registration Number: NCT00920959
• Lead Sponsor: GlaxoSmithKline

Brief Summary

To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 908

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluticasone propionate/salmeterol combination	FSC 100/50mcg	study drug
Fluticasone propionate	FP 100mcg	study drug
Placebo	Placebo	placebo

Primary Outcome Measures

Name	Time	Method
Change from baseline at endpoint in daily PM PEF	12 weeks

Secondary Outcome Measures

Name	Time	Method
Various pulmonary function endpoints	12 weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇷 San Juan, Puerto Rico