GSK BHR Study (Sont - Second Study)

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: FSC 100/50mcg; Drug: FP 100mcg; Drug: FSC 250/50mcg; Drug: FP 250mcg; Drug: FSC500/50mcg; Drug: FP 500mcg

• Registration Number: NCT01324362
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-03-25
• Study First Posted: 2011-03-29
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 446

Inclusion Criteria

• Diagnosis of asthma
• Controller asthma medication or medium dose ICS
• Current or historical reversibility

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluticasone propionate/salmeterol combination	FSC 100/50mcg	-
Fluticasone propionate/salmeterol combination	FSC 250/50mcg	-
Fluticasone propionate/salmeterol combination	FSC500/50mcg	-
Fluticasone propionate/salmeterol combination	Placebo	-
Fluticasone propionate	Placebo	-
Fluticasone propionate	FP 100mcg	-
Fluticasone propionate	FP 250mcg	-
Fluticasone propionate	FP 500mcg	-

Primary Outcome Measures

Name	Time	Method
Average ICS treatment dose over the treatment period	Every 8 weeks through 40 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Pulmonary function measures	Every 8 weeks through 40 weeks of treatment

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇷 San Juan, Puerto Rico