Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT01008761
Status:
UNKNOWN
Last Update Posted:
2012-07-12
First Post:
2009-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial for the Treatment of Acute Asthma in Wheezy Pre-school Aged Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D018942', 'term': 'Macrolides'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-11', 'studyFirstSubmitDate': '2009-11-04', 'studyFirstSubmitQcDate': '2009-11-05', 'lastUpdatePostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine if treatment of pre-school children with a history of wheeze who present to an Emergency department (ED) with an acute wheezing episode with Azithromycin for 5 days will resolve their symptoms more quickly', 'timeFrame': 'Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months'}], 'secondaryOutcomes': [{'measure': 'Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will cause these children to use less rescue beta2 agonists than those treated with placebo', 'timeFrame': 'Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months'}, {'measure': 'Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will allow these children to remain free of subsequent wheezy episodes longer than those treated with placebo.', 'timeFrame': 'Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pre-school child', 'Wheezy episode'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'To determine if treatment of pre-school children with a history of wheeze who present to an Emergency Department with an acute wheezing episode with azithromycin for 5 days will resolve their symptoms more quickly, will require less short acting beta agonist (SABA), and allow these children to remain symptom free for a longer period of time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12-60 months\n* wheeze on auscultation\n\nExclusion Criteria:\n\n* antibiotic use in the past 30 days\n* macrolide allergy\n* underlying medical condition\n* significant co-morbidities\n* current enrollment\n* language barrier or no access to phone for follow up'}, 'identificationModule': {'nctId': 'NCT01008761', 'briefTitle': 'Trial for the Treatment of Acute Asthma in Wheezy Pre-school Aged Children', 'organization': {'class': 'OTHER', 'fullName': "Alberta Children's Hospital"}, 'officialTitle': 'A Double Blind Randomized Control Trail of Azithromycin for the Acute Management of Wheezy Pre-school Children', 'orgStudyIdInfo': {'id': 'ALAWhZy2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Zithromax, 100 mgmgs; 5mls suspension', 'description': 'Azithromycin given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days Each syringe will contain 12.5 mls (250 mgs) sufficient drug to adequately dose children who with up to 25 kgs (95%tile for weight for 60 month old child)', 'interventionNames': ['Drug: Azithromycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Suspension placebo,', 'description': 'placebo (suspension produced by CDC Edmonton.) given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days.', 'interventionNames': ['Drug: Suspension Placebo']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['Azithromycin, zithromax, macrolide'], 'description': 'Azithromycin given at 10 mg/kg/day for day 1, then 5 mg/kg for 4 days Each syringe will contain 12.5 mls (250 mgs) sufficient drug to adequately dose children who with up to 25 kgs (95%tile for weight for 60 month old child)', 'armGroupLabels': ['Zithromax, 100 mgmgs; 5mls suspension']}, {'name': 'Suspension Placebo', 'type': 'DRUG', 'otherNames': ['Azithromycin'], 'description': 'Placebo suspension will be administered on day 1 at 10mg/kg and then for the next 4 days at 5 mg/kg', 'armGroupLabels': ['Suspension placebo,']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Janielee Williamson, RN', 'role': 'CONTACT', 'email': 'janie.williamson@albertahealthservices.ca', 'phone': '403-955-3186'}, {'name': 'Paula Finnson', 'role': 'CONTACT', 'email': 'paula.finnson@albertahealthservices.ca', 'phone': '403-955-7873'}, {'name': 'David Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sheldon Spier, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'James D Kellner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Candice Bjornson, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Surrette, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alberto Nettle-Aguire, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Alberta Children's Hospital", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2V7', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Piush Mandhane, MD', 'role': 'CONTACT', 'email': 'piush.mandhane@albertahealthservices.ca'}, {'name': 'Piush Mandhane, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'William Craig, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Darryl Adamko, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bonita Lee, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carina Majaesic, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Stollery Children's Hospital", 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'centralContacts': [{'name': 'Janielee Williamson, RN', 'role': 'CONTACT', 'email': 'janie.williamson@albertahealthservices.ca', 'phone': '403-955-3186'}, {'name': 'David W. Johnson, MD', 'role': 'CONTACT', 'email': 'david.johnson@alberthealthservices.ca', 'phone': '403-955-7507'}], 'overallOfficials': [{'name': 'David W Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Alberta children's Hospital/University of Calgary"}, {'name': 'Piush Mandhane, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Stollery Children's Hospital Edmonton"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janielee Williamson', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alberta', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'CCCRP Research Coordinator', 'investigatorFullName': 'Janielee Williamson', 'investigatorAffiliation': "Alberta Children's Hospital"}}}}