Status:
COMPLETED
SERETIDE 100/50 bd (Twice Daily) Versus FLIXOTIDE 100 bd As Initial Maintenance Therapy In Moderate Asthma In Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
Brief Summary
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 mod...
Detailed 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 fluticas...
Eligibility Criteria
Inclusion
- 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 (inhaled corticosteroids)
- 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 ≥ 5 packs year
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00461500
Start Date
March 1 2007
End Date
December 1 2007
Last Update
March 3 2017
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