GSK BHR Study (Sont)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Placebo; Drug: FSC 500/50mcg; Drug: FSC 250/50mcg; Drug: FP 100mcg; Drug: FSC 100/50mcg; Drug: FP 500mcg; Drug: FP 250mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00920543

SAM40086

Details and patient eligibility

About

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

Enrollment: 464 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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464 participants in 2 patient groups

Fluticasone propionate

Active Comparator group

Treatment:

Drug: FP 100mcg

Drug: Placebo

Drug: FP 500mcg

Drug: FP 250mcg

Fluticasone propionate/salmeterol combination

Active Comparator group

Treatment:

Drug: FSC 250/50mcg

Drug: Placebo

Drug: FSC 500/50mcg

Drug: FSC 100/50mcg