MULTICENTRIC STUDY, RANDOM SELECTION, DOUBLE-BLIND, CROSSBREAKING, COMPARING THE EFFECT OF L-454560 AND PLACEBO IN ADULT PATIENTS WITH CHRONIC ASTHMA.
- Conditions
- -J459 Asthma, unspecifiedAsthma, unspecifiedJ459
- Registration Number
- PER-065-02
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
The patient understands the study procedures and agrees to participate as indicated by signing the appropriate Informed Consent Document.
The patient has a medical history (of at least one year) consistent with persistent or intermittent asthma symptoms that include, but are not limited to;
dyspnea, wheezing, tightness in the chest, cough and sputum production.
The patient has a FEVi, while not using p-agonists for six hours, between 50% and 80% of the predicted value, documented at least twice during Visits 1, 2, and / or 3.
In the opinion of the investigator, the patient is mentally or legally incapacitated, which prevents the informed consent from being obtained; He is unable to read.
The patient shows significant abnormalities in the physical examination of Visit 1 or in laboratory measurements.
The patient has a recent history (within 3 months of Visit 1) of
a clinically symptomatic psychiatric disorder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method