None listed
Conditions
Interventions
montelukast 7 mg. Type of group
Montelukast IV of 7 mg is administered as a manual bolus, using a 3.3% dextrose diluent / 0.3% sodium chloride.
Group name:placebo Type of group
Montelukast IV 7 mg placebo is administered as a manual bolus, using a 3.3% dextrose diluent / 0.3% sodium chloride.
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: The patient is a male or female at least 15 years of age. Not pregnant. Asthma history of at least 1 year. During Period I, the patient has a forced expiratory volume in 1 second (FEV1) <50% of the predicted value in all measurements.
Exclusion criteria
Exclusion criteria: The patient has some known or suspected cause, acute or chronic. for your pulmonary symptoms other than asthma. Patients with fever. The patient has received any anti-asthmatic therapy other than oxygen, pagonists, anticholinergics, or corticosteroids. The patient has some comorbidity alteration different to asthma diagnosed by history, physical examination, or laboratory results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The change of the time-weighted average in FEV1 with respect to the baseline Measure:The time-weighted average change in FEV1 with respect to baseline pre-allocation in the first 60 minutes after study drug administration. Timepoints:60 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Patients who require hospitalization or patients who have not been made the decision to discharge them within 3 hours after the end of study drug administration. Measure:The percentage of treatment failures where the treatment fails. Timepoints:3 hours | — |
Countries
Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed