None listed
Conditions
Interventions
montelukast compared with placebo Type of group
Patients will receive placebo once daily during Period I. Patients will receive a 4-mg chewable tablet of montelukast or
matching placebo once daily at bedtime during Period II. Patients will receive 4-mg chewable tablet of montelukast once daily at bedtime or usual care during Period III. Patients allocated to the usual care group will be treated with inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the investigators usual clinical practice.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a. Patient is a male or female between and including the ages of 2 and 5 yeais at the Prestudy Visit. b. Parenl/legal guardian agrees to the patient´s participation in the study as indicated by parental/legal guardian signature on the consent form. The patient and parent/guardian are willing lo comply with procedures, and both patient and parent/guardian are able to keep scheduled clinic visits. The parent/guardian designated as the primary caregiver to the patient must remain the same throughout the study. c. Patient has a history of physician diagnosed asthma characterized by: At least three episodes within the past year of typical symptoms of asthma, including, but not limited to, cough, wheezing, and shonness of breath. d. Patient requires the use of p-agonist medication on a prespecified number of days during Period I (see Section E.3.e.). e. Patient has an asthma symptom score of 1 or more on a presp>ecified number of days during Period I (see Section E.3.d.). f. Patient is judged to be in otherwise good, stable health on the basis of medical history, physical examination, and routine laboratory data, and appears to be able to successfully complete this trial. g. Parenis/guardians are able to read and comprehend the questions on the diary card. h. Patient must be able to chew a tablet.
Exclusion criteria
Exclusion criteria: General a. Parent/guardian is, in the opinion of the invesiigator, mentally or legally incapacitated preventing informed consent from being obtained. b. Patient is hospitalized. c. Patient and/or parent/guardian intends to move or to vacation away from home for greater than 16 days during the course of the study. d. Patient has participated in a clinical trial involving an investigational or marketed dnig within 8 weeks of the Prestudy Visit. e. Patient has had any major surgical procedure within 4 weeks of the Prestudy Visit. Pulmonarv f. Patient has evidence of active, clinically significant sinus disease within 3 weeks of the Prestudy Visit. g. Patient has any active, acute, or chronic pulmonary disorder other than asthma documented by history or physical examination. h. Patient has required intubation for asthma in the past. i. Patient has required a visit to the emergency room due to an asthma exacerbation or has been hospitalized for asthma within 1 month of the Prestudy Visit. j. Patient has unresolved signs and symptoms of an upper or lower respiratory tract infection or has had an upper or lower respiratory tract infection within 3 weeks of the Prestudy Visit. General Medical k. Patient has a history of any clinically significant disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematological systems, or has hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with Measure:Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study Timepoints:12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Patients who were discontinued due to serious CAEs during 12 weeks of treatment Measure:Number of Patients Who Were Discontinued Due to Serious CAEs Timepoints:12 weeks | — |
Countries
Peru
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed