Montelukast in Acute RSV Bronchiolitis

Ziv Hospital

Status: Completed

Conditions: Bronchiolitis

Treatments: Drug: Placebo granules; Drug: Montelukast

Study type: Interventional

Funder types: Other

Identifiers

NCT00524693

HP-146-R

Details and patient eligibility

About

There is evidence of inflammatory mechanisms in RSV bronchiolitis with increased cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast (Singulair©) approved for use in infants as granule sachets, have become available. We evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute phase of RSV bronchiolitis.

Enrollment: 51 patients

Sex: All

Ages: 4 weeks to 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 4 weeks < 2 years
• Duration of respiratory symptoms < 4 days
• Signs of bronchiolitis: prodromal rhinorrhea and cough, followed by at least two of the following signs: chest retractions, tachypnea, wheezing, or rales
• First episode of wheezing or shortness of breath
• Randomization within 12 hours of admission
• No need for steroid treatment in the ward
• Informed consent

Exclusion criteria

• A history of asthma symptoms or any previous hospital admissions with respiratory tract illnesses and if they had ever been treated with anti-asthma medications (prior to the current illness).
• Underlying cardiopulmonary disease such as bronchopulmonary dysplasia, congenital heart disease, immunodeficiency, or cystic fibrosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

4mg Singulair© sachets

Treatment:

Drug: Montelukast

2

Placebo Comparator group

Treatment:

Drug: Placebo granules