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A Mulitcenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma - Pediatric IV Montelukast Study

A Mulitcenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma - Pediatric IV Montelukast Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002650-22-LT
Enrollment
300
Registered
2005-07-28
Start date
2005-09-20
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute asthma MedDRA version: 8.0 Level: LLT Classification code 10003553

Interventions

Product Name: MK-0476 FOR INJECTION Product Code: NA Pharmaceutical Form: Powder for injection* INN or Proposed INN: MONTELUKAST SODIUM Other descriptive name: NA Concentration unit: mg/ml milligram(s

Sponsors

Merck & Co., Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Pediatric asthmatic males and females (ages 6-14 years) seeking treatment for acute asthma. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Based upon history or physical examination at the study site, patient has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., pneumonia, cystic fibrosis, bronchopulmonary dysplasia, etc.).

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the clinical efficacy of intravenous (IV) montelukast 5.25 mg, with placebo, when administered as adjunctive therapy to pediatric patients with acute asthma on the primary endpoint (improvement in forced expiratory volume in 1 second [FEV1] over the first 60 minutes after administration);Secondary Objective: To estimate the effect of montelukast IV, compared with placebo, on the secondary endpoints (change from baseline in modified Pulmonary Index [mPI] score, incidence of treatment failures, and amount of additional therapy [short-acting ß-agonist] required). To estimate the onset of action (rate of FEV1 improvement) of montelukast IV, compared with placebo, when administered as adjunctive therapy in pediatric patients with acute asthma. To determine the safety and tolerability of montelukast IV when administered as adjunctive therapy in pediatric patients with acute asthma. ;Primary end point(s): The time weighted average change in FEV1 from preallocation baseline over the first 60 minutes after study drug administration (average ?FEV1[0-60 min]) with the time interval between any measurement and the measurement prior to it used as the weighting factor.—

Countries

Lithuania

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026