A DOUBLE-BLIND, CONTROLLED WITH PLACEBO, MULTICENTER, CROSSED STUDY TO EVALUATE THE EFFECTS OF A SINGLE ORAL DOSE OF MONTELUKAST, COMPARED WITH THE PLACEBO, IN BRONCHOCONSTRICTION INDUCED BY THE EXERCISE (EIB) IN PEDIATRIC PATIENTS FROM 4 TO 14 YEARS OLD AGE
- Conditions
- -J459 Asthma, unspecifiedAsthma, unspecifiedJ459
- Registration Number
- PER-096-07
- Lead Sponsor
- MERCK & CO.INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient has a history of IBD or wheezing and / or shortness of breath with exercise, with or without a diagnosis of persistent asthma.
• The parent / legal guardian of the patient agrees to the patient´s participation in the study as indicated by the signature of the parent / legal guardian in the consent form.
• The patient and his / her parent / guardian understand and are willing to comply with the study procedures and are willing to attend scheduled clinic visits.
• The patient (7 years of age and older) agrees to participate in the study as indicated by the patient´s signature in the consent form. The patient understands and is willing to comply with the study procedures and is willing to attend scheduled clinic visits.
• A potentially fertile female patient agrees to remain abstinent or continue to use an acceptable method of contraception. The patient must have initiated abstinence / contraception at least 14 days before signing informed consent and must continue until at least 14 days after Visit 6 or discontinuation visit. Acceptable methods of contraception are: oral contraceptives, intrauterine device (IUD), diaphragm, spermicide, contraceptive sponge, and male condom.
• The patient is male or female and has at least 4 and no more than 14 years of age in Visit 1.
• The patient is not a smoker.
• It is considered that the patient, regardless of his or her illness, is stable and in good health, according to medical history, physical examination and laboratory safety information (including a negative urine b-hCG test, if applicable). ).
• The patient is able to perform acceptable reproducible spirometry tests.
• The patient has a FEVi based! before exercise> 70% of what was expected (see Appendix 6.1) at Visit 2 ^, after having suspended the use of immediate-action p-agonists for> 8 hours and of caffeine for> 8 hours.
• J. The patient has presented evidence of IBD, defined as a decrease in FEV] (in liters) of at least 20% within 60 minutes after the standardized stress test in Visit 2 (compared to the value of baseline FEV1 before exercise measured 5 minutes before exercise). For example, if the baseline FEV] is 2.0L, then to qualify for the study, the FEV | after the exercise should be <1.6L.
• The patient is able to perform acceptable reproducible spirometry tests.
• The patient has a FEV]. Baseline before exercise> 70% of that predicted in Visit 3 after having suspended the use of-P-agonists for immediate action for> 8 hours and caffeine for> 8 hours.
• The patient has presented evidence of IBD, defined as a decrease in FEV] (in liters) of at least 20% within 60 minutes of the standardized stress test in Visit 3 (compared to the FEV value) ] baseline before exercise measured 5 minutes before exercise, see example in j above).
• The patient is able to perform acceptable reproducible spirometry tests.
• The patient and / or the parent / legal guardian, according to the opinion of the investigator, is mentally or legally incapacitated, which prevents the consent and / or informed consent from being obtained.
• The patient has participated in a clinical trial that included the use of an investigational drug or marketed within 4 weeks prior to Visit 1.
• 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.
• The patient is pregnant and / or has a {3-hCG test in urine or positive serum.
• The patient is a woman who has <8 weeks postpartum or is breastfeeding a baby.
• The patient is not willing to perform the stress test or the spirometry maneuvers.
• The patient has an excessive intake of caffeine or drinks that contain caffeine (more than four drinks with caffeine / day).
• The patient has had an asthma exacerbation within 4 weeks prior to Visit l (ie, needs a change in the type, dose or frequency of the drugs and / or needs an unscheduled visit to a provider. health care, including the emergency room or hospital).
• In addition to asthma, the patient has an active, acute or chronic pulmonary disorder, documented with history, physical examination or chest x-rays.
• The patient shows signs and / or unresolved symptoms of an upper respiratory infection within 2 weeks prior to Visit 1. Visits can be rescheduled to take place at least 2 weeks after the visits have disappeared. signs and / or symptoms of URI.
• The patient has ever been intubated because of his asthma, has needed acute asthma therapy, has been treated in an emergency room / emergency room / office within the previous month or has been hospitalized for asthma within of the three months prior to Visit 1.
• The patient is hospitalized.
• The patient has undergone a major surgery procedure, has suffered a major trauma that requires medical attention or a significant illness that required medical attention within 4 weeks prior to Visit 1.
• The patient has a history of anaphylactic allergic reaction related to the administration of a commercialized or investigational drug, or has hypersensitivity to inhaled p-agonists or montelukast.
• The patient has a recent history (within three months prior to Visit 1) of any clinically significant psychiatric disorder. It differs from mild depression (which does not interfere with work or social activities).
• The patient has a history of any clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurological, genitourinary renal or hematological systems.
• The patient has a history of any disease that could require treatment with an excluded drug, which could put his life at risk immediately (for example, ventricular arrhythmia, incompletely cured or treated neoplasia in the last 3 months, unstable diabetes mellitus ), could mean a restriction for the participation or successful completion of the study, or that would pose an additional risk to the patient if the study drug is administered.
• The patient has significant or unexplained abnormalities in the physical examination and / or laboratory safety tests in Visit 1 (see Appendix 6.4).
• The patient has taken any of the following drugs / therapies within the designated time period prior to Visit 1 (patients will be instructed to refrain from taking these drugs during the course of
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method