None listed
Conditions
Interventions
Group 1 Type of group
montelukast (CT of 4- or 5- mg) daily plus placebo (equivalent to CT of 4- or 5- mg) as intermittent cycles of 12 days, as needed
Group name:Group 3 Type of group
placebo (equivalent to 4 or 5 mg CT) daily plus placebo (equivalent to 4 or 5 mg CT) as intermittent 12-day cycles, as needed.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is a boy or girl between 6 months and 5 years (71 months) of age inclusive. • The parent / legal guardian agrees that the patient participate in the study as indicated by the signature of the parent / legal guardian in the informed consent. The patient and the parent / legal guardian are willing to comply with the procedures and both the patient and the parent / guardian can keep scheduled clinical visits. • In the case of patients 2 years of age: the patient has a history of episodic asthma symptoms, so that in the 12 months prior to Visit 1, the patient had at least 3, but not more than 6, symptoms of asthma episodes (for example, coughing, wheezing, shortness of breath) for approximately 3 days, each of which included, at a minimum, treatment with p-agonists, and one of these episodes occurred within the 6 months prior to Visit 1, and the episodes are separated from each other for periods of time without asthma symptoms (this information can be obtained as a verbal medical history provided by the parent / guardian). • In the case of patients> 1 year of age: In the 12 months prior to Visit 1, the patient had at least one treatment with corticosteroids (oral, rectal, inhaled or parenteral) OR was hospitalized at least once a cause of asthma (this information can be obtained as a verbal medical history provided by the parent / guardian). In the case of patients 2 years of age: the patient can chew a tablet.
Exclusion criteria
Exclusion criteria: • The parent / guardian is, in the opinion of the investigator, mentally or legally incapacitated, which prevents the signing of informed consent. • The patient is hospitalized. • The patient has participated in a clinical trial that involves a drug under investigation or commercialized within the 8 weeks prior to Visit 1. • The patient has had some major surgical procedure within 4 weeks prior to Visit 1. • The patient has an active, clinically significant disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary or hematological systems or has hypertension. • The patient presents a history of some clinically significant adverse event of a serious nature related to the administration of any commercialized or investigational drug (eg, angioedema, anaphylaxis) or, otherwise, is sensitive to drugs marketed or under investigation. • The patient presents significant or unexplained abnormalities in the physical examination of Visit 1. • The patient has a history of persistent symptoms of asthma so that diurnal symptoms occur> once a week and nocturnal symptoms occur> twice a month. • The patient presents any acute or chronic active lung disorder, different from asthma, documented by history or physical examination. • The patient has required, in the past, intubation due to asthma. • The patient has some unresolved sign or symptom of an acute episode of asthma in the last 2 weeks. • The patient has some sign or symptom of a respiratory tract infection in the last 2 weeks. • The patient has some evidence of active sinus disease, clinically important in the last 4 weeks. • The patient is receiving immunotherapy. • The patient has used long-term control drugs (inhaled corticosteroids, leukotriene modifiers, cromolina / nedocromil or theophylline) in the last 2 weeks OR: In the case of patients 2 months, cumulatively. In the case of patients> 2 years of age: for> 4 months, cumulatively, in the 12 months 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 and / or the parent / guardian are unable or unwilling to comply with the study procedures, including adequate entry of the information in the diary and compliance with the study drug. • The patient has significant or unexplained abnormalities in the laboratory safety tests (Appendix 2). • The patient and the parent / guardian are not trained or are not willing to comply with the study procedures, as determined during Period 1, including adequate entry of the information in the diary and compliance with the drug. study. • The patient and the parent / guardian are not trained or unwilling to comply with the study procedures, as determined during Period I, including adequate entry of the information in the diary and compliance with the drug. study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:For each patient, the number of asthma attacks that occur within the episodes of asthma during the 1-year treatment period will be counted. For this analysis, only one asthma attack per episode of asthma will be counted. Measure:Number of asthma episodes that culminate in an asthma attack Timepoints:12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the daily average of the mean symptom scores (wheezing and respiratory distress) evaluated for 3 days before the first asthma attack within the episode. If a patient has more than one episode of asthma that ends in asthma attack, the average is calculated from multiple asthma attacks. The end point will be calculated for patients who have episodes of asthma that culminate in an asthma attack. Measure:The severity of the symptom Timepoints:During the study ; Outcome name:The severity of the symptom defined as the daily average of the mean symptom scores (wheezing, respiratory distress, interference with activity and cough) assessed during the 12-day treatment period of the asthma episodes. If a patient has multiple episodes during the study period of 1 year, the average is calculated from the different episodes. For patients who have an episode of asthma that culminates in an asthma attack, only the symptom score recorded before the asthma attack will be taken into account. The end point will be calculated for all patients. Measure:The severity of the symptom Timepoints:12 months ; Outcome name:The number of asthma attacks that occur during the 1-year study period, whether the attacks occur or not within an episode of asthma. Measure:Number of asthma attacks that occur during the 1-year study period Timepoints:12 months | — |
Contacts
Public ContactSTELA Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed