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

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: montelukast sodium; Drug: Comparator: placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00117338

2005_026

0476-301

MK0476-301

Details and patient eligibility

About

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.

Full description

The duration of treatment is a one time dose.

Enrollment: 276 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

276 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: placebo (unspecified)

2

Active Comparator group

Description:

montelukast sodium

Treatment:

Drug: montelukast sodium