Montelukast in Acute RSV Bronchiolitis

Overview[ - collapse ][ - ]

Purpose 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.
ConditionBronchiolitis
InterventionDrug: Montelukast
Drug: Placebo granules
PhaseN/A
SponsorZiv Hospital
Responsible PartyZiv Hospital
ClinicalTrials.gov IdentifierNCT00524693
First ReceivedSeptember 4, 2007
Last UpdatedSeptember 4, 2007
Last verifiedSeptember 2007

Tracking Information[ + expand ][ + ]

First Received DateSeptember 4, 2007
Last Updated DateSeptember 4, 2007
Start DateJanuary 2006
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresLength of stay [Time Frame: hours]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleMontelukast in Acute RSV Bronchiolitis
Official TitleA Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionBronchiolitis
InterventionDrug: Montelukast
4mg sachets
Other Names:
Singulair©Drug: Placebo granules
Study Arm (s)
  • Active Comparator: 1
    4mg Singulair© sachets
  • Placebo Comparator: 2

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment51
Estimated Completion DateNot Provided
Estimated Primary Completion DateNot Provided
Eligibility Criteria
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.
GenderBoth
AgesN/A
Accepts Healthy VolunteersNot Provided
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00524693
Other Study ID NumbersHP-146-R
Has Data Monitoring CommitteeNo
Information Provided ByZiv Hospital
Study SponsorZiv Hospital
CollaboratorsWolfson Medical Center
Investigators Principal Investigator: Israel Amirav, MD Ziv Medical Center
Verification DateSeptember 2007