Study Of Airway Physiology In Adults. SERETIDE DISKUS® Inhaler and FLIXOTIDE® Inhaler Are Trademarks of GSK Croup of Companies.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Salmeterol/fluticasone propionate and fluticasone propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00370591

SAM40104

Details and patient eligibility

About

Comparison of two asthma treatments by lung function measures.

Full description

Single centre, randomised, double-blind, comparator study to demonstrate superiority of salmeterol/fluticasone propionate combination product 50/100mcg bd over fluticasone propionate 100mcg bd with respect to improvements in airway physiology (sRAW) in adults with persistent asthma treated for 4 weeks.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Physician documented diagnosis of asthma which has been present for at least 6 months.
• Receiving a total daily dose of 200-500mcg/day beclomethasone dipropionate or equivalent for at least 4 weeks prior to the start of the run-in period.

Exclusion:

• Has had 3 or more courses of oral corticosteroids in the 12 months previous to visit 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Salmeterol/fluticasone propionate and fluticasone propionate