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Montelukast in Acute RSV Bronchiolitis

NCT ID: NCT00524693

Last Updated: 2007-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

4mg Singulair© sachets

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

4mg sachets

2

Group Type PLACEBO_COMPARATOR

Placebo granules

Intervention Type DRUG

Interventions

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Montelukast

4mg sachets

Intervention Type DRUG

Placebo granules

Intervention Type DRUG

Other Intervention Names

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Singulair©

Eligibility Criteria

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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.
Minimum Eligible Age

4 Weeks

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role collaborator

Ziv Hospital

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Israel Amirav, MD

Role: PRINCIPAL_INVESTIGATOR

Ziv Medical Center

References

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Amirav I, Luder AS, Kruger N, Borovitch Y, Babai I, Miron D, Zuker M, Tal G, Mandelberg A. A double-blind, placebo-controlled, randomized trial of montelukast for acute bronchiolitis. Pediatrics. 2008 Dec;122(6):e1249-55. doi: 10.1542/peds.2008-1744. Epub 2008 Nov 4.

Reference Type DERIVED
PMID: 18984650 (View on PubMed)

Other Identifiers

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HP-146-R

Identifier Type: -

Identifier Source: org_study_id