Study Of Airway Physiology In Adults.
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on August 03, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Salmeterol/fluticasone propionate and fluticasone propionate (Drug)
Phase: Phase 4
Status: No longer recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: Glaoxsmithkline
Summary
Comparison of two asthma treatments by lung function measures.
Clinical Details
Official title:
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.
Study design: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
GSK Clinical Trials Call Center, Manchester, North-West M23 9GP, United Kingdom
Additional Information
Starting date:
December 2003
Last updated: August 30, 2006
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