EXTENDED, MULTICENTER, CONTROLLED OPEN LABELED STUDY ON THE SAFETY OF MONTELUKAST IN BABIES AND SMALL CHILDREN WITH CHRONIC ASTHMA
- Conditions
- -J451 Nonallergic asthmaNonallergic asthmaJ451
- Registration Number
- PER-038-01
- 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
• The patient successfully completed Visit 5 of Protocol 176-01, which includes the competent maintenance of the weekly Asthma Calendar by the parent / legal guardian.
• The parent / legal guardian accepts the patient´s participation in the study as indicated by the signature of the parent / legal guardian on the consent form. The parent / legal guardian is willing to comply with the procedures and both the patient and the parent / legal guardian can make scheduled clinic visits.
• In the opinion of the investigator, the parent / legal guardian is mentally or legally incapacitated, which prevents the obtaining of informed consent.
• The patient is hospitalized.
• The patient has experienced a clinically important serious adverse event, which is still present during the Pre-study Visit.
• The patient has participated in a Clinical Study that involves a drug or vaccine under investigation or commercialized, which is not that of Protocol 176-01, within the 8 weeks prior to the Pre-study Visit.
• The patient has undergone an important surgical procedure within 4 weeks prior to the Pre-study visit.
• The patient is allergic to apples or applesauce.
• The patient has developed or been diagnosed with an active, acute or chronic lung disease outside of asthma that has been documented in his or her history or physical examination.
• Since Visit 5 of Protocol 176-01, the patient has needed intubation or mechanical ventilation.
• The patient has had to go to an emergency room due to an asthma exacerbation or has been hospitalized for asthma within 2 weeks prior to the Pre-study visit.
• The patient has unresolved signs and symptoms of an upper or lower respiratory tract infection in the Pre-study Visit.
• The patient has developed or has been diagnosed with any of the following medical conditions: cystic fibrosis, tuberculosis, foreign body aspiration, bronchopulmonary dysplasia, tracheomalacia, tracheoesophageal fistula, gastroesophageal reflux, pertussis or congenital heart disease.
• The patient has developed some clinically significant adverse experience of a serious nature related to the administration of a commercialized or investigational drug (for example: angioedema, anaphylaxis) or is otherwise sensitive to commercialized or investigational drugs.
• The patient has developed or has been diagnosed with a congenital disease or disease that could immediately affect his or her life (for example: arrhythmias, congenital heart disease, labile diabetes, partially healed neoplasia or treated in the last 3 months), which would represent a restriction for the participation or successful completion of the study or that represent an additional risk for the administration of montelukast to the patient.
• The patient has significant or unknown abnormalities in the physical examination and / or laboratory safety tests of the pre-study visit
• The patient has used oral or parenteral corticosteroids within 2 weeks prior to the Pre-study visit.
• The patient has used theophylline within 2 weeks of the Pre-study visit.
• The patient has used antileukotriene agents within 2 weeks of the Pre-study visit.
• The patient has had an increase in dose or a therapy with cromoglycate or nedocromil inhaled / nebulized that has recently been instituted within 2 weeks of the Pre-study visit.
• The patient has had an increase in dose or has recently been reinstituted a therapy with inhaled / nebulized corticosteroids within 2 weeks prior to the Pre-study visit.
• The patient is in a situation or has a condition that, at the discretion of the investigator, may interfere with their optimal participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Incidents of adverse experiences by body system reported by parents / legal representatives<br>Measure:General incidence of adverse experiences and incidences of adverse experiences by body system reported by parents / legal representatives.<br>Timepoints:At the end of the study<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Days without beta-agonists<br>Measure:Days without beta-agonists<br>Timepoints:At the end of the study<br>;<br>Outcome name:Clinical evaluation of signs and symptoms<br>Measure:Study discontinuations due to symptoms of worsening asthma<br>Timepoints:At the time of discontinuities<br>;<br>Outcome name:Rescues with oral corticosteroids for symptoms of worsening asthma<br>Measure:Rescues with oral corticosteroids for symptoms of worsening asthma<br>Timepoints:During treatment<br>;<br>Outcome name:Visits to emergency rooms or non-scheduled hospital visits due to symptoms of worsening asthma and total eosinophil counts in peripheral blood.<br>Measure:Visits to emergency rooms or non-scheduled hospital visits due to symptoms of worsening asthma and total eosinophil counts in peripheral blood.<br>Timepoints:At the end of treatment<br>