GSK BHR Study (Sont - Second Study)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: FSC500/50mcg; Drug: FP 500mcg; Drug: FP 100mcg; Drug: Placebo; Drug: FSC 100/50mcg; Drug: FSC 250/50mcg; Drug: FP 250mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01324362

SAM40065

Details and patient eligibility

About

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

Enrollment: 446 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

446 participants in 2 patient groups

Fluticasone propionate

Active Comparator group

Treatment:

Drug: Placebo

Drug: FP 100mcg

Drug: Placebo

Drug: FP 500mcg

Drug: FP 250mcg

Fluticasone propionate/salmeterol combination

Active Comparator group

Treatment:

Drug: Placebo

Drug: FSC500/50mcg

Drug: Placebo

Drug: FSC 100/50mcg

Drug: FSC 250/50mcg