NCT00524693

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
Last Updated

September 5, 2007

Status Verified

September 1, 2007

First QC Date

September 4, 2007

Last Update Submit

September 4, 2007

Conditions

Bronchiolitis

Keywords

Bronchiolitiscontrolled clinical trialpediatricsInfantsmontelukastRespiratory syncytial virus

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    hours

Study Arms (2)

1

ACTIVE COMPARATOR

4mg Singulair© sachets

Drug: Montelukast

2

PLACEBO COMPARATOR
Drug: Placebo granules

Interventions

MontelukastDRUG

4mg sachets

Also known as: Singulair©
1
Placebo granulesDRUG
2

Eligibility Criteria

Age4 Weeks - 2 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18984650DERIVED

MeSH Terms

Conditions

Bronchiolitis

Interventions

montelukast

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Israel Amirav, MD

    Ziv Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 5, 2007

Study Start

January 1, 2006

Last Updated

September 5, 2007

Record last verified: 2007-09