Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-05 @ 5:56 PM
Study NCT ID:
NCT01868932
Status:
WITHDRAWN
Last Update Posted:
2015-11-13
First Post:
2013-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Wheezing in Children With Hypertonic Saline (TWICS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001988', 'term': 'Bronchiolitis'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding declined. Study never initiated.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-12', 'studyFirstSubmitDate': '2013-05-28', 'studyFirstSubmitQcDate': '2013-05-30', 'lastUpdatePostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of admission to hospital', 'timeFrame': 'duration of hospital ER stay, an average of 4 hours', 'description': 'Rates of admission to hospital'}], 'secondaryOutcomes': [{'measure': 'Improvement in respiratory distress scores after initial protocol treatment in the ED', 'timeFrame': 'time from pre-intervention assessment to post-intervention assessment, an average of 2 hours', 'description': 'Improvement in respiratory distress scores after initial protocol treatment in the ED'}, {'measure': 'Length-of-stay in the ED in the subgroup of patients not admitted', 'timeFrame': 'an average of 6 hours', 'description': 'Length-of-stay in the ED in the subgroup of patients not admitted'}, {'measure': 'Cumulative dose of bronchodilator administered in ED prior to admission/discharge order', 'timeFrame': 'an average of 6 hours', 'description': 'Cumulative dose of bronchodilator administered in ED prior to admission/discharge order'}, {'measure': 'Length of hospital stay in the those who are admitted', 'timeFrame': 'length of hospital stay, an average of 3 days', 'description': 'Length of hospital stay in the those who are admitted'}, {'measure': 'Rate of return visit to ED (for respiratory illness) within 14 days of enrollment', 'timeFrame': '14 days', 'description': 'Rate of return visit to ED (for respiratory illness) within 14 days of enrollment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['wheeze', 'early childhood', 'asthma', 'bronchiolitis', 'infection triggered'], 'conditions': ['Wheeze']}, 'descriptionModule': {'briefSummary': 'Hypothesis: substitution of nebulized 3% NaCl (HS) for the standard normal saline (NS) used in bronchodilator therapy for acute viral wheezing in all children under age 6 years will provide superior symptom relief leading to decreased admission rates from the Emergency Department.\n\nThe study will test the efficacy of frequent doses of inhaled bronchodilator co-administered with either 3% hypertonic saline (HS, study group) or 0.9% normal saline (NS, control group) in a prospective, double blind, randomized controlled, multi-centre clinical trial of children under age 6 years presenting to the ED with acute viral-associated wheezing.', 'detailedDescription': 'the brief summary captures the essence of the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age under 6 years\n2. History of viral upper respiratory infection within previous 7 days\n3. Wheezing or crackles detected on chest auscultation\n4. Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.\n\nExclusion Criteria:\n\n1. History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.\n2. Severe illness at presentation as defined by any of the following\n\n * respiratory rate greater than 80/min\n * SaO2 less than 88% in room air\n * need for assisted ventilation\n3. Use of nebulized HS within previous 12 hours\n4. Presence of active varicella infection.'}, 'identificationModule': {'nctId': 'NCT01868932', 'acronym': 'TWICS', 'briefTitle': 'Treating Wheezing in Children With Hypertonic Saline (TWICS)', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Treating Wheezing in Children With Hypertonic Saline (TWICS)', 'orgStudyIdInfo': {'id': 'TWICS'}, 'secondaryIdInfos': [{'id': 'HSTWICS', 'type': 'OTHER', 'domain': "Queen's Department of Pediatrics"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hypertonic saline', 'description': 'inhalation of 4 ml nebulized study solution containing 3% hypertonic saline (HS, study group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) 1,2 added by the ED staff. Initial therapy will consist of 3 consecutive nebulizations given in rapid succession (back-to-back, approximately every 20 minutes).', 'interventionNames': ['Other: hypertonic saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'saline', 'description': 'inhalation of 4 ml nebulized study solution containing saline 0.9% saline (NS, control group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) 1,2 added by the ED staff. Initial therapy will consist of 3 consecutive nebulizations given in rapid succession (back-to-back, approximately every 20 minutes).', 'interventionNames': ['Other: saline']}], 'interventions': [{'name': 'hypertonic saline', 'type': 'OTHER', 'otherNames': ['nebulized hypertonic saline', 'aerosolized hypertonic saline'], 'description': 'inhaled nebulized 3%NaCl', 'armGroupLabels': ['hypertonic saline']}, {'name': 'saline', 'type': 'OTHER', 'otherNames': ['nebulized saline', 'aerosolized saline'], 'description': 'inhaled nebulized 0.9% NaCl', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael Flavin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Michael Flavin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Dr. Michael Flavin', 'investigatorAffiliation': "Queen's University"}}}}