A DOUBLE-BLIND, RANDOMIZED, MULTI-CENTRAL STUDY OF 3 PERIODS, CROSSED TO EVALUATE THE EFFECTS OF A SINGLE DOSE OF MONTELUKAST COMPARED TO THE PLACEBO AND SALMETEROL IN BRONCHOCONSTRICTION INDUCED BY EXERCISE
- Conditions
- J45-J45
- Registration Number
- PER-059-05
- Lead Sponsor
- MERCK & CO.INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. The patient is a man or woman who is between 15 and 45 years old.
2. The patient understands the study procedures and is willing to participate in the study.
3. The patient is considered to have good and stable health.
4. The patient presents evidence of IBD.
5. The patient has stable asthma without exacerbations.
6. The patient has not smoked for at least 6 months and has a history of having smoked no more than 15 packs per year.
7. The patient has a baseline FEV1 before exercise> 70% of what was expected.
8. The patient is able to perform reproducible tests of lung function.
1. The patient is under the age established to give legal consent and the consent of the parent or guardian has not been obtained.
2. The patient is, in the opinion of the investigator, mentally or legally incapacitated.
3. The patient has donated a unit of blood within the 4 weeks prior to Visit 1.
4. 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.
5. The patient is currently a regular user, or has a recent history of abuse of alcohol or illicit drugs.
6. The patient is a woman who has <8 weeks post-partum or is breast-feeding a baby.
7. The patient is pregnant and / or has a B-hCG test in serum or positive urine.
8. The patient is in a situation or has a condition that, in the opinion of the investigator, may interfere with their optimal participation in the study.
9. The patient is not able to perform the stress test or the spirometry procedures.
10. The patient is hospitalized.
11. The patient has undergone a major surgery procedure, has suffered a major trauma that requires medical attention or a significant illness that requires medical attention within 4 weeks prior to Visit 1.
12. The patient has a history of anaphylactic allergic reaction related to the administration of a commercialized or investigational drug, or has hypersensitivity to inhaled B-agonists or montelukast.
13. The patient has a history of a clinically significant disease.
14. The patient has evidence of a disease that may require treatment with an excluded medication.
15. The patient presents significant or unexplained abnormalities in the physical examination and / or laboratory tests.
16. The patient has a precipitous fall in FEV1 after exposure to exercise.
17. The patient requires rescue treatment with immediate-action B-agonists after the physical exertion test and does not return to be within 20% of the baseline FEV1.
18. The patient has had an exacerbation of asthma within the previous 4 weeks.
19. The patient shows signs and / or unresolved symptoms of an upper respiratory tract infection within 4 weeks of Visit 1.
20. The patient has been exposed to cold air sufficiently to produce symptoms of bronchospasm within 2 hours prior to the physical exertion test at Visit 1.
21. The patient has exercised or performed strenuous activities within 72 hours prior to Visit 1.
22. In addition to asthma, the patient has an active, acute or chronic pulmonary disorder documented with history, physical examination or chest x-ray.
23. The patient has hypertension, diabetes mellitus, hypercholesterolemia, hyperlipidemia or a history of these conditions.
24. The patient has a systolic blood pressure of> 150 mm Hg or diastolic blood pressure of> 95 mm Hg in> 2 measurements made with> 5 minutes interval in Visit 1.
25. The patient presents ECG abnormalities consistent with previous myocardial infarction, hypertrophic cardiomyopathy, ischemic heart disease or conduction system disease.
26. The patient has a heart murmur that the investigator considers clinically and / or hemodynamically important.
27. The patient presents evidence of ischemic, valvular, hypertrophic, familial heart disease or other forms of heart disease.
28. The patient has used oral or parenteral corticosteroids within 12 weeks prior to Visit 1.
29. The patient has had a change in the dose of controller th
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Spirometry before and after the exercise test.<br><br>Measure:Primary Efficacy: Maximum percentage drop in FEV1 with respect to the baseline.<br>Timepoints:5 minutes before the exercise test and 5, 10, 15, 30 and 60 minutes later.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Spirometry before and after the exercise test.<br>Measure:Secondary efficiency: Percent drop of the area under the curve for the percentage fall in FEV1 with respect to the baseline. Time elapsed for the recovery from the maximum percentage fall in FEV1 to within 5% of the baseline value prior to the exercise. Number of patients requiring rescue with immediate-action beta agonists within 90 minutes after the physical exertion test.<br><br>Timepoints:Spirometry: 5 minutes before the exercise test and 5, 10, 15, 30 and 60 minutes later.<br>Clinical examination: Within 90 minutes after the stress test.<br>;<br>Outcome name:Physical examination and taking of vital signs.<br>Laboratory tests.<br>12-lead electrocardiogram.<br>Measure:Safety.<br>Timepoints:Before starting the treatment. They will be repeated only if the researcher considers it appropriate.<br>