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Completed

NCT Number: NCT00524693

Montelukast in Acute RSV Bronchiolitis

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.

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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

4 week–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

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

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.

Treatment and study plan

Montelukast

Drug

4mg sachets

Other names: Singulair©

Placebo granules

Drug

Primary outcomes

  1. Length of stay

    Time frame: hours

Sponsors and collaborators

Lead sponsor

Ziv Hospital

Other Gov

Collaborators

  • Wolfson Medical Center

Registry information

Official study title

A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis

Important dates

Study start
2006
First posted
Sep 5, 2007
Registry last updated
Sep 5, 2007

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.

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