A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTI-CENTRAL, 2-PERIOD STUDY CROSSED TO EVALUATE THE EFFECTS OF A SINGLE DOSE OF MONTELUKAST IN THE BRONCHESPASM INDUCED FOR THE YEAR
- Conditions
- -J95J95
- Registration Number
- PER-036-04
- 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
to. Male or female who is between 15 and 45 years old.
b. Signature of the patient in the informed consent or approval.
c. The patient presents evidence of IBD, defined as a decrease in FEV1 (in liters) by at least 20% after exposure to standard exercise in Visit 1
a. The patient is younger than the one established for legal consent and the consent of the parent or guardian has not been obtained.
b. The patient is, according to the opinion of the researcher, mentally or legally disabled, which prevents obtaining informed consent, or does not know how to read or does not understand the written material.
c. The patient has donated a unit of blood within the 4 weeks prior to Visit 1.
d. The patient has participated in a clinical trial that involves the use of a research drug or marketed within 4 weeks prior to Visit 1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:FEV1<br>Measure:Maximum percentage decrease in FEV1 compared to the baseline before exercise that is obtained within the first 60 minutes after exposure to exercise.<br>Timepoints:60 minutes after the exhibition<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:physical examinations, obtaining vital signs, blood and urine for safety laboratory measurements and electrocardiograms before the speech<br>Measure:Measuring the safety of montelukast<br>Timepoints:day 3<br>