None listed
Conditions
Interventions
Montelukast Type of group
Single oral dose of montelukast, administered as a 10 mg coated tablet, to prevent bronchospasm induced by exercise at 2, 12 and 24 hours after dosing.
Group name:Placebo Type of group
Single oral dose of placebo montelukast, administered as a 10 mg coated tablet, to prevent exercise-induced bronchospasm at 2, 12 and 24 hours after dosing.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:FEV1 Measure:Maximum percentage decrease in FEV1 compared to the baseline before exercise that is obtained within the first 60 minutes after exposure to exercise. Timepoints:60 minutes after the exhibition | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:physical examinations, obtaining vital signs, blood and urine for safety laboratory measurements and electrocardiograms before the speech Measure:Measuring the safety of montelukast Timepoints:day 3 | — |
Countries
Peru
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed