Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-31 @ 5:37 AM
Study NCT ID:
NCT01677403
Status:
UNKNOWN
Last Update Posted:
2012-12-05
First Post:
2012-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014031', 'term': 'Tobramycin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D009328', 'term': 'Nebramycin'}, {'id': 'D007612', 'term': 'Kanamycin'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-04', 'studyFirstSubmitDate': '2012-08-26', 'studyFirstSubmitQcDate': '2012-08-29', 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate change in density of Pseudomonas aeruginosa in sputum', 'timeFrame': 'days 1,7,14'}], 'secondaryOutcomes': [{'measure': 'To evaluate chang in the amount of sputum', 'timeFrame': 'days 1,7,14'}, {'measure': "To evaluate chang in patients' cough severity", 'timeFrame': 'days 1,7,14'}, {'measure': 'To evaluate change in pulmonary function', 'timeFrame': 'days 1,7,14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bronchiectasis', 'Tobramycin', 'nebulised'], 'conditions': ['Bronchiectasis']}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate the efficacy,indications,adverse reactions and resistance of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis.', 'detailedDescription': 'Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation, microbial infection, a persistent inflammatory response with the release of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis varies, but the presence of microbial infection and a persistent inflammatory response is typical of the disease. The chronic nature of the infection and the associated considerable morbidity provides the rationale for using aerosolized antibiotics for the treatment of bronchiectasis patients.\n\nThis is a study of safety and efficacy of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis. Study subjects will be randomized to receive either study drug or placebo by inhalation via a nebulizer. Each subject will complete 14 days of daily dosing.\n\nClinical laboratory parameters,clinical adverse events and pulmonary function will be evaluated for all study subjects in order to determine the qualitative and quantitative safety and efficacy of nebulized tobramycin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female study subjects ≥18 years of age and ≤80 years of age\n2. Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis\n3. Confirmation of infection with P. aeruginosa at screening\n4. Are sensitive to Tobramycin\n5. Acute exacerbation of bronchiectasis -\n\nExclusion Criteria:\n\n1. Bronchiectasis due to special causes.\n2. Smokers.\n3. Are associated with bronchial asthma.\n4. Have any serious or active medical or psychiatric illness.\n5. Are not tolerant to nebulised tobramycin\n6. FEV1.0 reduces ≥ 15% after inhaling tobramycin. -'}, 'identificationModule': {'nctId': 'NCT01677403', 'briefTitle': 'A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'A Randomized,Controlled Study to Evaluate the Efficacy,Indications,Adverse Reactions and Resistance of Combined Administration of Nebulized Tobramycin Compared With Systemic Administration Alone in Patients With Bronchiectasis', 'orgStudyIdInfo': {'id': 'qlhqiqian'}, 'secondaryIdInfos': [{'id': 'QL', 'type': 'REGISTRY', 'domain': 'QQian'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nebulised Tobramycin', 'description': 'Nebulised Tobramycin', 'interventionNames': ['Drug: Tobramycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nebulised 0.9% Saline', 'description': 'Nebulised 0.9% Saline', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Tobramycin', 'type': 'DRUG', 'description': 'Nebulised 80mg twice daily', 'armGroupLabels': ['Nebulised Tobramycin']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Nebulised 5mls 0.9% Saline twice daily', 'armGroupLabels': ['Nebulised 0.9% Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250100', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Qi', 'role': 'CONTACT', 'email': 'xiaokangqlh@163.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Qi Qian', 'investigatorAffiliation': 'Shandong University'}}}}