SERETIDE 100/50 bd Versus FLIXOTIDE 100 bd As Initial Maintenance Therapy In Moderate Asthma In Adults
This study will compare during 12 weeks, two treatment strategies for Initial Maintenance Therapy : fluticasone propionate alone or the salmeterol/fluticasone propionate combination in adults with moderate persistent...
Brief Summary
Official Title: “See Detailed Description”
This study will compare during 12 weeks, two treatment strategies for Initial Maintenance Therapy : fluticasone propionate alone or the salmeterol/fluticasone propionate combination in adults with moderate persistent asthma
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: December 2007
Detailed Clinical Trial Description
A multicentre randomised, double-blind, parallel-group study to compare the salmeterol/fluticasone propionate combination (SERETIDETM DISKUSTM 50/100) 50/100µg one inhalation twice daily with fluticasone propionate (FLIXOTIDETM DISKUSTM 100) 100µg one inhalation twice daily as initial maintenance therapy for 12 weeks in adults with persistent moderate asthma
Intervention(s) in this Clinical Trial
- Drug: SERETIDE FLIXOTIDE
Outcome Measures for this Clinical Trial
Primary Measures
- to demonstrate that salmeterol/fluticasone propionate combination 50/100µg DISKUS (SFC100) is more effective than fluticasone propionate 100µg DISKUS (FP100) on PEF, in the initial maintenance therapy in persistent moderate asthma
Secondary Measures
- To demonstrate that SFC100 bd is more effective than FP100 bd on FEV1 and on time to reach first week of asthma control. To demonstrate in a sub-group of patients, that SFC100 bd is more effective than FP100 bd, in reducing air trapping.
- pre-dose FEV1 ; FVC ; FEF25-75% ; asthma control ; Daily Record Card assessment ; exacerbations ; ACT ; CT-scan ; safety ; AQLQ
Criteria for Participation in this Clinical Trial
Inclusion criteria:
- male or female ≥ 18; documented history of asthma; reversibility FEV1 or PEF ≥ 12% (post 400µg salbu); moderate asthma (daily symptoms, daily rescue use, PEF = 60-80% predicted value) ; naive or ≥ 4weeks-free ICS
Exclusion criteria:
- respiratory disorder; FEV1<60% predicted ; exacerbation/respiratory infection ≤ 4 weeks ; oral/parenteral/depot corticosteroids ≤ 6 months; LABA/oral β2 agonist/ ALT/ theophylline ≤ 4 weeks; smoker or former smoker ≥ 5PY
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 40 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: GlaxoSmithKline Industry
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00461500
Study ID Number: SAM108037
ClinicalTrials.gov Identifier: NCT00461500
Health Authority: France: Afssaps - French Health Products Safety Agency
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00461500
