None listed
Conditions
Interventions
Group 1 Type of group
Patients 12 to 23 months of age will receive doses of 4 mg of oral granules, while patients of 2 to 5 years of age will receive 4 mg chewable tablets. Daily for 52 weeks
Group name:Group 3 Type of group
Placebo orally for 52 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is a boy or girl from 1 (12 months) to 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 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 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 1 time because of asthma (this information can be obtained as a history verbal medical provided by the parent / guardian). • It is determined that in other aspects the patient is well, with stable health according to the medical history, physical examination and baseline / routine laboratory information and seems to be able to satisfactorily complete this test. • Parents / guardians are able to read and understand the questions that appear in the diary. • 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 8 weeks prior to Visit 1. • The patient has had some major surgical procedure within 4 weeks prior to Visit 1. • The patient has some active, clinically significant disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary systems • hematologic or hypertension. • The patient has a history of a 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 commercialized or investigational drugs. • 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
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. Measure:Number of asthma episodes that culminate in an asthma attack Timepoints:12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:as the average daily of the average scores of symptoms (wheezing and respiratory distress) evaluated during 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 final point will be calculated for patients who have episodes of asthma that culminate in an asthma attack .. Measure:Severity of the symptoms Timepoints:evaluated during 3 days before the first asthma attack within the episode ; Outcome name:An asthma attack begins on the first day that the patients asthma symptoms require HRU, which includes unscheduled visits to the doctor or the emergency department, treatment with corticosteroids (oral, rectal, inhaled or parenteral) or hospitalization. The asthma attack culminates the first day of a sequence of 7 consecutive days without HRU. Measure:The number of asthma attacks that occur during the 1-year study period. Timepoints:12 months ; Outcome name:An episode of asthma begins the day the intermittent treatment begins. The episode of asthma ends when the intermittent treatment of the episode ends (the treatment lasts 12 calendar days) or when a No response is recorded for both questions of the Symptom Schedule, whichever is the longest. Measure:The number of asthma episodes that occur during the 1-year study period. Timepoints:12 months ; Outcome name:An asthma-free day is a day without symptoms, without the use of b-agonist and without HRU. Measure:The percentage of asthma-free days during the 1-year study period. Timepoints:12 months ; Outcome name:An episode of asthma begins the day the intermittent treatment begins. The episode of asthma ends when the intermittent treatment of the episode ends (the treatment lasts 12 calendar days) or when a No response is recorded for both questions of the Symptom Schedule, whichever is the longest. Measure:T | — |
Contacts
Public ContactSTELA Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed