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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370591
First Posted: August 31, 2006
Last Update Posted: September 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
August 30, 2006
August 31, 2006
September 15, 2016
December 2002
April 2004   (Final data collection date for primary outcome measure)
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. SERETIDE DISKUS® Inhaler and FLIXOTIDE® Inhaler Are Trademarks of GSK Croup of Companies.
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 Twice Daily
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Asthma
Drug: Salmeterol/fluticasone propionate and fluticasone propionate
Experimental: Arm 1
Intervention: Drug: Salmeterol/fluticasone propionate and fluticasone propionate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2004
April 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00370591
SAM40104
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

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