GSK BHR Study (Sont)

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: FP 100mcg; Drug: FSC 100/50mcg; Drug: FP 500mcg; Drug: FSC 250/50mcg; Drug: FP 250mcg; Drug: FSC 500/50mcg

• Registration Number: NCT00920543
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study was to determine whether asthma control and reduced bronchial hyperresponsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS twice-daily or FP twice-daily in adult and adolescent subjects with persistent asthma

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 464

Inclusion Criteria

• Asthma diagnosis
• Controller medications or moderate inhaled corticosteroid dose
• Evidence of reversibility

Exclusion Criteria

• Life-threatening asthma
• Asthma instability
• Concurrent respiratory disease
• Drug allergy
• Respiratory tract infection
• Systemic corticosteroid use
• Immunosuppressive medication use
• Positive pregnancy test
• Tobacco use
• Site affiliation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluticasone propionate	FP 250mcg	-
Fluticasone propionate	FP 500mcg	-
Fluticasone propionate/salmeterol combination	FSC 250/50mcg	-
Fluticasone propionate	Placebo	-
Fluticasone propionate	FP 100mcg	-
Fluticasone propionate/salmeterol combination	Placebo	-
Fluticasone propionate/salmeterol combination	FSC 500/50mcg	-
Fluticasone propionate/salmeterol combination	FSC 100/50mcg	-

Primary Outcome Measures

Name	Time	Method
Average inhaled corticosteroid treatment dose over the treatment period	Every 8 weeks for the 40 week treatment period

Secondary Outcome Measures

Name	Time	Method
Pulmonary function measures	Every 8 weeks for the 40 week treatment period

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇷 Ponce, Puerto Rico