Study Of Airway Physiology In Adults.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00370591
First received: August 30, 2006
Last updated: September 5, 2013
Last verified: August 2013

August 30, 2006
September 5, 2013
December 2002
Not Provided
Specific airway resistance (sRAW kPa.L.s) measured before the study medication dose at the end of treatment (week 4)
Same as current
Complete list of historical versions of study NCT00370591 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study Of Airway Physiology In Adults.
Randomised, Double Blind, Parallel Group Study to Assess the Bronchodilative and Bronchoprotective Properties of Seretide Diskus 50/100 Mcg Bid vs Flixotide 200 Mcg Bid

Comparison of two asthma treatments by lung function measures.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
Drug: Salmeterol/fluticasone propionate and fluticasone propionate
Other Name: Salmeterol/fluticasone propionate and fluticasone propionate
Not Provided
Houghton CM, Lawson N, Borrill ZL, Wixon CL, Yoxall S, Langley SJ, Woodcock A, Singh D. Comparison of the effects of salmeterol/fluticasone propionate with fluticasone propionate on airway physiology in adults with mild persistent asthma. Respir Res. 2007 Jul 14;8:52.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
Not Provided
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00370591
SAM40104
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP