Clinical Trial: Study Of Airway Physiology In Adults. SERETIDE DISKUS® Inhaler and FLIXOTIDE® Inhaler Are Trademarks of GSK Croup of Companies.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomised, Double Blind, Parallel Group Study to Assess the Bronchodilative and Bronchoprotective Properties of SERETIDE DISKUS® Inhaler 50/100 mcg Twice Daily vs FLIXOTIDE® Inhaler 200 mcg
Brief Summary: Comparison of two asthma treatments by lung function measures.
Detailed Summary: 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.
Sponsor: GlaxoSmithKline
Current Primary Outcome: Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4)
Original Primary Outcome: Same as current
Current Secondary Outcome: sRAW measured post-dose at Week 2 and week 4. % symptom-free days over Weeks 1-4. % symptom-free nights over Weeks 1-4. Type and frequency of adverse events.
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: August 30, 2006
Date Started: December 2002
Date Completion:
Last Updated: September 13, 2016
Last Verified: September 2016