None listed
Conditions
Interventions
Group 1 Type of group
1) Pre-study phase: Start of standard therapy according to clinical evaluation: B-agonists, anticholinergics, corticosteroids, oxygen. Duration: 60 min
2) Period I: Selection of patients who meet the inclusion criteria. Duration: 60 min
3) Period II: Montelukast for IV use will be supplied in a dose of 7 mg in vials protected from light. Montelukast will be reconstituted in 20 mL of 3.3% dextrose / 0.3% sodium chloride. In a syringe, 15 mL of the reconstituted study drug will be placed to
1) Pre-study phase: Start of standard therapy according to clinical evaluation: B-agonists, anticholinergics, corticosteroids, oxygen. Duration: 60 min 2) Period I: Selection of patients who meet the inclusion criteria. Duration: 60 min 3) Period II: Montelukast Placebo for IV use will be supplied 15 mL. The preparation is administered as a manual bolus for 2 to 5 minutes. Period II will continue until the discontinuation of the study, discharge of the patient or admission to the hospital
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: a) The patient is a man or a woman from 6 to 14 years of age. b) The patient who has begun to menstruate has a pregnancy test in serum or urine with negative results before randomization. c) The patient presents at the study site for the treatment of symptoms that coincide with an asthma exacerbation. d) The patient has a history of symptoms similar to asthma on at least 1 occasion, which occurs at least within 3 months prior to the current episode. e) During Period I, the patient has an mPI score of> 6 in both measurements. f) The patient has a FEV1 <or equal to 75% of the predicted value in the baseline spirometry measurement taken just before randomization. g) The parent / caregiver and the patient accept the patient s participation in the study. h) The patient is within the 3rd and 97th percentile of height range and weight-for-age range.
Exclusion criteria
Exclusion criteria: a) The patient has some known or suspected cause, acute or chronic, for his pulmonary symptoms other than asthma. b) The asthma that the patient suffers has characteristics that threaten life. c) The time between the start of standard treatment for acute asthma at the study site and the administration of the study drug exceeds 120 minutes. d) The patient has a comorbid disorder other than asthma. e) The patient has received an oral leukotriene receptor antagonist or an inhibitor of leukotriene synthesis within 24 hours prior to randomization. f) The patient has received some anti-asthma therapies other than oxygen, B-agonists, anticholinergics or corticosteroids between the presentation in the ED and the randomization. g) The patient has an active, clinically significant disease of the gastrointestinal, cardiovascular, hepatic, neurological, psychiatric, renal, genitourinary or hematological systems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Spirometry Measure:Weighted average of the time of the change of the Volume of Forced Expiration in the First Second (FEV1) Timepoints:15, 30, 45, 60 and 120 minutes after the administration of the study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:mPI scale Measure:Change with respect to the baseline in the Modified Lung Index score (mPI) evaluated 60 minutes after the administration of the drug. Timepoints:60 minutes after the start of treatment ; Outcome name:Percentage of treatment failures: Clinical evaluation: If the patient requires hospitalization or decision to discharge. Total dose of B-agonist administered. : Clinical evaluation. Time to decide hospitalization: Clinical evaluation. The time for the decision to hospital discharge: Clinical evaluation. The change in oxygen saturation .: Clinical evaluation Measure:Percentage of treatment failures. Total dose of B-agonist administered. Time to decide hospitalization. The time for the decision to hospital discharge. The change in oxygen saturation. Timepoints:Percentage of treatment failures: At the time of the event. Total dose of B-agonist administered. : 2 hours after treatment. Time to decide hospitalization: At the time of presenting the event. The time for the decision to hospital discharge: At the time of presenting the event. The change in oxygen saturation: 2 hours after treatment. | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed