None listed
Conditions
Interventions
Group 1 Type of group
4 mg of montelukast in granules (mixed with 1 tablespoon of applesauce once a day at night)
Group name:Group 2 Type of group
They will receive usual care, which consists of inhaled / nebulized cromoglycate or nedocromil or inhaled / nebulized corticosteroids.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Incidents of adverse experiences by body system reported by parents / legal representatives Measure:General incidence of adverse experiences and incidences of adverse experiences by body system reported by parents / legal representatives. Timepoints:At the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Days without beta-agonists Measure:Days without beta-agonists Timepoints:At the end of the study ; Outcome name:Clinical evaluation of signs and symptoms Measure:Study discontinuations due to symptoms of worsening asthma Timepoints:At the time of discontinuities ; Outcome name:Rescues with oral corticosteroids for symptoms of worsening asthma Measure:Rescues with oral corticosteroids for symptoms of worsening asthma Timepoints:During treatment ; Outcome name:Visits to emergency rooms or non-scheduled hospital visits due to symptoms of worsening asthma and total eosinophil counts in peripheral blood. Measure:Visits to emergency rooms or non-scheduled hospital visits due to symptoms of worsening asthma and total eosinophil counts in peripheral blood. Timepoints:At the end of treatment | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed