Montelukast in Acute RSV Bronchiolitis

Z

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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