EUCTR2006-005998-21-FR
Active, not recruiting
Phase 1
A multicentre randomised, double-blind, parallel-group study to compare the salmeterol xinafoate/fluticasone propionate combination (Seretide® Diskus® 50/100) 50/100 micrograms one inhalation twice daily with fluticasone propionate (Flixotide® Diskus® 100) 100 micrograms one inhalation twice daily as initial maintenance therapy for 12 weeks in adults with persistent moderate asthma.
aboratoire GlaxoSmithKline0 sites0 target enrollmentJanuary 11, 2007
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- aboratoire GlaxoSmithKline
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria for entry into the run\-in period
- •1\- Male or female adult aged \=18 years
- •2\- A documented clinical history of asthma
- •3\- A documented diagnosis of asthma on lung function based on airway reversibility of \=12% in the last 2 years or at visit 1 based on either FEV1 or PEF measured pre and post inhalation of 400µg salbutamol (possible to demonstrate at Visit 2 for subjects who failed to demonstrate at Visit 1\)
- •4\- A diagnosis of moderate persistent asthma defined as
- •\- daily symptoms
- •\- daily rescue use
- •5\- Inhaled corticosteroid\-naive or inhaled corticosteroid\-free (i.e.; no inhaled corticosteroids for at least 12 weeks prior to Visit 1\)
- •6\- Able to use the Mini\-Wright peak flow meter
- •7\- Able to complete a DRC
Exclusion Criteria
- •Exclusion criteria for entry into the run\-in period
- •1\-Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function
- •2\- FEV1\< 60% predicted
- •3\- Subjects who have participated in any study using an investigational drug during the previous 4 weeks prior to Visit 1
- •4\- Subjects who have an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to Visit 1
- •5\- Acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalization within 12 weeks of Visit 1 or at Visit 1
- •6\- Use of oral parenteral or depot corticosteroid within 6 months of Visit 1
- •7\- Use of long\-acting inhaled beta2\-agonist or oral beta2\-agonist within 4 weeks of Visit 1
- •8\- Use of Anti\-leucotrienes, including suppressors of leukotriene production and leukotriene antagonists or theophyllines within 4 weeks of Visit 1
- •9\- Known clinical or laboratory envidence of a serious uncontrolled disease (including serious psychological disorders) likely to interfere with the study
Outcomes
Primary Outcomes
Not specified
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