A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)

NCT ID: NCT00117338

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2008-03-31

Brief Summary

This study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone.

Detailed Description

The duration of treatment is a one time dose.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: placebo (unspecified)

Intervention Type: DRUG

Pbo for a study approximately 120 minutes in duration

2

montelukast sodium

Group Type: ACTIVE_COMPARATOR

montelukast sodium

Intervention Type: DRUG

Montelukast IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration

Interventions

montelukast sodium

Montelukast IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration

Intervention Type: DRUG

Comparator: placebo (unspecified)

Pbo for a study approximately 120 minutes in duration

Intervention Type: DRUG

Other Intervention Names

MK0476; SINGULAIR®

Eligibility Criteria

Inclusion Criteria

• Children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks

Exclusion Criteria

• Other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Morris CR, Becker AB, Pinieiro A, Massaad R, Green SA, Smugar SS, Gurner DM. A randomized, placebo-controlled study of intravenous montelukast in children with acute asthma. Ann Allergy Asthma Immunol. 2010 Feb;104(2):161-71. doi: 10.1016/j.anai.2009.11.065.

Reference Type: DERIVED

PMID: 20306820 (View on PubMed)

Other Identifiers

MK0476-301

Identifier Type: -

Identifier Source: secondary_id

2005_026

Identifier Type: -

Identifier Source: secondary_id

0476-301

Identifier Type: -

Identifier Source: org_study_id