A MULTI-CENTER STUDY OF 52 WEEKS, RANDOMIZED, DOUBLE-BLIND, DOUBLED MASKED, CONTROLLED WITH PLACEBO AND PARALLEL GROUPS, TO COMPARE THE EFFECTIVENESS AND TOLERABILITY OF THE COMBINATION WITH SALMETEROL / PROPIONATO DE FLUTICASONA (SERETIDE / VIANI / ADV)
- Conditions
- -J45J45
- Registration Number
- PER-026-02
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Male or female with an age> 12 years
• Who are currently receiving b2 short-acting inhaled agonists.
• That they are able to comply with the therapy and correctly complete the Daily Registration Cards.
• Have a documented history of asthma for a period of at least 6 months.
• That they have received research medication in the study within 4 weeks prior to the first visit or that they are participating concurrently in another clinical trial.
• That they are using oral / parenteral corticosteroids or deposit in a period of 12 weeks prior to the first visit.
• That they are using inhaled corticosteroids within 12 weeks of the first visit.
• That they are using receptor antagonists for leukotrienes within 12 weeks prior to the first visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Symptoms of asthma exacerbation.<br>Measure:Frequency of asthma exacerbations over the weeks.<br>Timepoints:1 - 52 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Forced expiratory flow<br>forced vital capacity<br>Measure:Forced forced expiratory flow (FEF) between 25% and 75% of forced vital capacity<br>Timepoints:52 week<br>