Trial of Montelukast for Treatment of Acute Bronchiolitis

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.

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

3 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast sodium

Drug

4mg granules daily for 14 days

Other names: singulair

Sucrose

Other

table sugar as placebo daily for 14 days

Primary outcomes

Duration of Cough

Time frame: up to 4 weeks

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled Trial of Daily Montelukast for the Treatment of Viral Bronchiolitis

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Mar 18, 2009
Registry last updated: Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed