None listed
Conditions
Interventions
Group 1 Type of group
Montelukast will be administered at a dose of 4 mg (or 2 mg) in granules mixed with 1 tablespoon of apple compote once a day, every day, at night for 6 weeks.
Group name:Group 2 Type of group
Placebo will be administered daily for 6 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is male or female and is between> 6 months and <24 months of age. • The patient is in the 5th to 95th percentile for height and weight by age • 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 / guardian is willing to comply with the procedures and both the patient and the parent / guardian may make the scheduled clinical visits. • It is considered that the patient is otherwise in good physical condition according to the medical history, the physical examination and the usual laboratory information. • The patient has received solid food for at least 1 month. • The patient has received applesauce or another product containing apple for at least 1 week before the Pre-study Visit (Visit 1). • Parents / guardians can read and understand the asthma calendar. • The patient has experienced at least 3 episodes of asthma or asthma-like symptoms (including, but not limited to, coughing, wheezing and shortness of breath), all of which occurred 8 weeks after birth and before the Visit Pre-study (Visit 1). • The patient has symptoms that agree, at least, with the asthma classified in Step 2 of the GINA guidelines as demonstrated by the response that the parent / guardian provides in letter b for the 2 questions of the Baseline Questionnaire of Asthma.
Exclusion criteria
Exclusion criteria: • In the opinion of the investigator, the parent / guardian is mentally or legally incapacitated, which prevents the obtaining of informed consent. • The patient is hospitalized. • The patient has participated in a clinical trial that involves a drug or vaccine under investigation or commercialized within 8 weeks of the Pre-study visit. • The patient has undergone some important surgical procedure within 4 weeks of the Pre-study visit. • The patient is allergic to apples or applesauce. Pulmonary • The patient was born prematurely (that is, less than 28 weeks of gestation). • The patient has some active, acute or chronic lung disease, apart from asthma, documented by his history or a physical examination. • The patient has required intubation for asthma in the past. • The patient has had to go to an emergency due to an asthma exacerbation or has been hospitalized for asthma within 2 weeks of the Pre-study visit. • The patient has unresolved signs and symptoms of an upper or lower respiratory tract infection in the Pre-study Visit. General Practitioners • The patient has a history of any of the following medical conditions; cystic fibrosis, tuberculosis, foreign body aspiration, bronchopulmonary dysplasia, tracheomalacia, tracheoesophageal fistula, gastroesophageal reflux, pertussis, congenital heart disease. • The patient has a history of some clinically significant adverse experience of a serious nature related to the administration of a marketed or investigational drug (eg, angioedema, anaphylaxis) or is otherwise sensitive to commercial or investigational drugs. • The patient has a history of a congenital illness or disease that could immediately threaten his life (for example: arrhythmias, congenital heart disease, labile diabetes, partially healed neoplasia or treated in the last 3 months), which represent a restriction for the participation or successful completion of the study or that would 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 pre-study laboratory safety tests Previous / Concurrent Medications • The patient has used drugs with known activities of inhibition or induction of metabolism of P-450 (such as phenobarbital, phenytoin, rifampin, erythromycin, trimethoprim / sulfaraetoxazole, ketoconazole [or other azoles]) within 2 weeks of the visit Pre-study • The patient has used astemizole within 3 months of the Pre-study visit, or terfenadine, ketotifen, anticholinergic and / or loratadine, within 2 weeks of the Pre-study visit. • The patient has used oral or parenteral corticosteroids within 2 weeks of the Pre-study visit. • The patient has used theophylline or anticholinergics within 2 weeks of the Pre-study visit. • The patient has used leukotriene agents within 2 weeks of the Pre-study visit. • The patient has had an increase in dose or a therapy with cromolin 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 a therapy with inhaled / nebulized corticosteroids that has recently been instituted within 2 weeks of the Pre-study visit. Procedural • 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 stu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluations (physical exams), monitoring of adverse experiences and laboratory safety tests. Measure:Safety Timepoints:Visits 1. 2 y 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The following will be evaluated: (1) Days without using b-agonists; (2) Study discontinuations due to symptoms of worsening asthma; (3) Rescues with oral coiticosteroids for symptoms of worsening asthma; (4) Number of doctor visits or unscheduled emergency visits due to symptoms of worsening asthma; (5) Total eosinophil counts in peripheral blood. Measure:Efficacy Timepoints:On the last visit | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed