MULTICENTER, DOUBLE-BLIND, RANDOMIZED, CROSS-OVER DESIGN STUDY TO EVALUATE THE EFFECT OF MONTELUKAST AGAINST SALMETEROL IN THE INHIBITION OF INDUCTION OF BRONCHOCONSTRICTION INDUCED BY EXERCISES IN ASTHMATIC PATIENTS OF 6 TO 14 YEARS OF AGE
- Conditions
- -J45J45
- Registration Number
- PER-058-05
- 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 and / or the person in charge of the patient´s care understands the procedures of the study and agrees to participate in it.
2) The patient is a child between 6 years of age and at least 14 years of age.
3) The patient has been a regular user of inhaled corticosteroids (ICS).
4) The patient complies with ALL the signs and symptoms of asthma.
5) The patient does not currently consume cigarettes.
6) The patient is able to do exercises in a treadmill.
7) The patient is considered to have good and stable mental and physical health.
8) A forced expiratory volume in one second (FEVi)> 70% of the predicted value, while the B-agonist is suspended for at least 6 hours.
1. Consent may not be obtained from the parent or guardian.
2. The patient is legally incompetent or mentally disabled.
3. The patient is hospitalized.
4. The patient has undergone major surgery within 4 weeks of Visit 1.
5. The patient has participated in a clinical trial that involves the use of an investigational drug or a commercial drug within 4 weeks of Visit 1.
6. The patient suffers from an active, acute or
chronic.
7. The patient has unresolved signs and symptoms of upper respiratory tract infection (URI) within 1 week of Visit 1.
8. The patient shows evidence of a clinically significant active nasal sinus infection.
9. The patient has ever been intubated for asthma, has required therapy for acute asthma, which was treated in an emergency room / urgent care center / office within the month prior to Visit 1, or has been hospitalized for asthma within three months prior to Visit 1.
10. The patient has a recent history of a clinically significant psychiatric disorder.
11. The patient has a history of an anaphylactic allergic reaction related to the administration of either an investigational or commercial drug, or, otherwise, is hypersensitive to salbuterol, salmeterol, fluticasone or montelukast.
12. The patient suffers from an active, clinically significant disease.
13. The patient has a history of any disease that would require treatment with an excluded medication.
14. The patient has taken any of the prohibited drugs within the designated time before Visit 1.
15. The patient has initiated immunotherapy within six months prior to Visit 1.
16. The patient has significant or unexplained abnormalities in laboratory measurements.
17. The potentially fertile patient demonstrates a level of B-hCG indicating a state of gravidity.
18. The patient has unresolved signs and symptoms of upper respiratory tract infection (URI) during the transition period.
19. The patient is unable or unwilling to comply with the study procedures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Spirometry test and exposure to the exercises.<br>Measure:Primary Efficacy: Maximum percentage reduction in FEV1 after the exercises.<br>Timepoints:Weeks -4, -2, 0, 4 and 10.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Spirometry test and exposure to the exercises.<br>Clinical evaluation.<br>Measure:Secondary efficiency: - AUC 0-20min. Maximum percentage of FEV1 predicted after the first administration of B agonist. Time to recovery after administration of B agonist. Average percentage change in FEV1 after administration of B-agonist.<br>Timepoints:Weeks -4, -2, 0, 4 and 10.<br>;<br>Outcome name:Clinical evaluation.<br>Laboratory safety tests: Hb, Hct, WBC, platelets, BUN, creatinine, total bilirubin, AST, ALT, alkaline phosphatase, glucose, B-HCG.<br>Measure:Safety: monitoring of adverse effects and laboratory tests.<br><br>Timepoints:Monitoring of adverse effects: when they occur.<br>Laboratory safety tests: Weeks -4, -2 and 10.<br>