Trial of Montelukast for Treatment of Acute Bronchiolitis

Medical College of Wisconsin

Status: Completed

Conditions: Bronchiolitis

Treatments: Drug: montelukast sodium; Other: sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT00863317

FDP-01

IND 103263 (Other Identifier)

Details and patient eligibility

About

The primary rationale for this study is to evaluate the effect of once daily montelukast on duration of acute illness in infants with first-time bronchiolitis.

Enrollment: 141 patients

Sex: All

Ages: 3 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female infants aged 3 to 12 months of age
• Diagnosis by emergency physician of bronchiolitis

Exclusion criteria

• Any previous episode, as determined by a physician, of wheezing, bronchiolitis or asthma
• Any history of previous bronchodilator use prior to this illness
• Treatment with corticosteroids in the 14 days prior to the current illness
• Immunosuppression
• Immunodeficiency
• Caregiver does not speak English
• Diagnosis by the treating ED physician of croup
• Diagnosis by the treating ED physician of pneumonia
• Caregiver does not have access to a telephone

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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141 participants in 2 patient groups, including a placebo group

montelukast sodium

Experimental group

Description:

4mg granules PO QD for 14 days

Treatment:

Drug: montelukast sodium

Placebo

Placebo Comparator group

Description:

Sucrose granules PO QD for 14 days

Treatment:

Other: sucrose