SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
An 18 months randomised double-blind study with two parallel arms with start dose of inhaled SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be up-titrated until well controlled is achieved, After 6 months the treatment continues without changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that the combination therapy with SERETIDE controls mild persistent asthma better than inhaled corticosteroids(FLIXOTIDE) alone.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||SERETIDE vs FLIXOTIDE in Mild Persistent Asthma (GINAII)|
- Number of patients in each arm with a need of an increase of study medication
- Bronchial hyperresponsiveness, number of symptom free days and nights, number of exacerbations, time to first exacerbation, time to increase of study medication
- 1. Bronchial hyper-responsiveness both change from baseline and change in values at the end of the study.
- 2. Number of symptom-free days and nights without use of rescue medication.
- 3. Number of exacerbations. 4. Time to first exacerbation. 5. Time to increase of study medication
|Study Start Date:||May 2005|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455923
|GSK Investigational Site|
|Luleå, Sweden, SE-971 89|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|