Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-23 @ 11:06 AM
Study NCT ID:
NCT00524693
Status:
COMPLETED
Last Update Posted:
2007-09-05
First Post:
2007-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Montelukast in Acute RSV Bronchiolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001988', 'term': 'Bronchiolitis'}], 'ancestors': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'lastUpdateSubmitDate': '2007-09-04', 'studyFirstSubmitDate': '2007-09-04', 'studyFirstSubmitQcDate': '2007-09-04', 'lastUpdatePostDateStruct': {'date': '2007-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bronchiolitis', 'controlled clinical trial', 'pediatrics', 'Infants', 'montelukast', 'Respiratory syncytial virus'], 'conditions': ['Bronchiolitis']}, 'referencesModule': {'references': [{'pmid': '18984650', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '4 Weeks', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 4 weeks \\< 2 years\n* Duration of respiratory symptoms \\< 4 days\n* Signs of bronchiolitis: prodromal rhinorrhea and cough, followed by at least two of the following signs: chest retractions, tachypnea, wheezing, or rales\n* First episode of wheezing or shortness of breath\n* Randomization within 12 hours of admission\n* No need for steroid treatment in the ward\n* Informed consent\n\nExclusion Criteria:\n\n* 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).\n* Underlying cardiopulmonary disease such as bronchopulmonary dysplasia, congenital heart disease, immunodeficiency, or cystic fibrosis.'}, 'identificationModule': {'nctId': 'NCT00524693', 'briefTitle': 'Montelukast in Acute RSV Bronchiolitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ziv Hospital'}, 'officialTitle': 'A Double-Blind Placebo Controlled Randomized Trial of Montelukast in Acute Respiratory Syncytial Virus Bronchiolitis', 'orgStudyIdInfo': {'id': 'HP-146-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '4mg Singulair© sachets', 'interventionNames': ['Drug: Montelukast']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo granules']}], 'interventions': [{'name': 'Montelukast', 'type': 'DRUG', 'otherNames': ['Singulair©'], 'description': '4mg sachets', 'armGroupLabels': ['1']}, {'name': 'Placebo granules', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Israel Amirav, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziv Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}]}}}