Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-03-02 @ 4:04 PM
Study NCT ID:
NCT02045550
Status:
UNKNOWN
Last Update Posted:
2014-01-27
First Post:
2014-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance and Effect of a Prophylactical Treatment With Ivy Leaves Dry Extract in Recurrent Wheezy Bronchitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001991', 'term': 'Bronchitis'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-23', 'studyFirstSubmitDate': '2014-01-13', 'studyFirstSubmitQcDate': '2014-01-23', 'lastUpdatePostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the time to event (next bronchitis episode) rate during and after treatment period', 'timeFrame': 'three months'}], 'secondaryOutcomes': [{'measure': 'days and percentage of days without bronchitis during and after treatment period', 'timeFrame': '3 months'}, {'measure': 'days and percentage of days without bronchitis during treatment period', 'timeFrame': 'three months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Wheezy Bronchitis', 'Recurrent Bronchitis']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of a prophylactical therapy with a cough medicine containing ivy leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the duration of the bronchitis episodes, on the severity and the additional drug demand. A prolonged asymptomatic episode between each wheezy bronchitis due to the therapy is assumed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Medical diagnosis of ≥3 episodes of wheezy bronchitis within the pre-vious 12 months\n2. Children aged from 1 to 3 years (girls and boys)\n3. Signed Informed Consent of the legal guardians to participate in the trial after written and verbal briefing by the Investigator\n4. No allergic sensitization\n5. Allowance to contact the familys pediatrician for medical history of wheezy bronchitis episodes\n\nExclusion Criteria:\n\n1. Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure\n2. Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial\n3. Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance)\n4. Inability to document the symptoms in a symptom log book or ques-tionnaire; inability to take the trial medication properly\n5. Any regular therapy except Vitamin D or Fluoride\n6. Chronic illnesses of different aetiology\n7. Premature birth or diagnosis of bronchopulmonary dysplasia\n8. Gastro-oesophageal reflux\n9. Hereditary fructose intolerance'}, 'identificationModule': {'nctId': 'NCT02045550', 'briefTitle': 'Tolerance and Effect of a Prophylactical Treatment With Ivy Leaves Dry Extract in Recurrent Wheezy Bronchitis', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Tolerance and Effect of a Prophylactical Treatment With a Cough Medicine Con-taining Ivy Leaves Dry Extract in Children With Recurrent Wheezy Bronchitis', 'orgStudyIdInfo': {'id': 'HeHe02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Syrup', 'description': 'Placebo Syrup 2.5 ml twice daily for 4 weeks'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prospan Syrup', 'description': 'Prospan Syrup 2.5 ml twice daily for 4 weeks', 'interventionNames': ['Drug: Prospan Syrup']}], 'interventions': [{'name': 'Prospan Syrup', 'type': 'DRUG', 'description': '2.5 ml twice daily for 4 weeks', 'armGroupLabels': ['Prospan Syrup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Vogelberg, MD PhD', 'role': 'CONTACT', 'email': 'christian.vogelberg@uniklinikum-dresden.de', 'phone': '0049351458', 'phoneExt': '2073'}, {'name': 'Sabine Zeil, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christian Vogelberg, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'centralContacts': [{'name': 'Christian Vogelberg, MD PhD', 'role': 'CONTACT', 'email': 'christian.vogelberg@uniklinikum-dresden.de', 'phone': '0049351458', 'phoneExt': '5699'}], 'overallOfficials': [{'name': 'Christian Vogelberg, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technische Universität Dresden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}