Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-29 @ 12:56 PM
Study NCT ID:
NCT00749866
Status:
COMPLETED
Last Update Posted:
2010-08-10
First Post:
2008-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Nebulised Gentamicin in Patients With Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005839', 'term': 'Gentamicins'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-09', 'studyFirstSubmitDate': '2008-09-08', 'studyFirstSubmitQcDate': '2008-09-08', 'lastUpdatePostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in bacterial load', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'airways and systemic inflammation', 'timeFrame': '1 year'}, {'measure': 'Spirometry and exercise capacity', 'timeFrame': '1 year'}, {'measure': 'Exacerbation frequency', 'timeFrame': '1 year'}, {'measure': 'Health Related Quality of Life', 'timeFrame': '1 Year'}, {'measure': 'Long term safety with nebulised Gentamicin', 'timeFrame': '1 Year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nebulised antibiotics', 'Non cystic fibrosis bronchiectasis', 'Bacterial Load', 'Inflammation', 'Quality of Life', 'Side Effects'], 'conditions': ['Bronchiectasis']}, 'referencesModule': {'references': [{'pmid': '22744718', 'type': 'DERIVED', 'citation': 'Chalmers JD, Smith MP, McHugh BJ, Doherty C, Govan JR, Hill AT. Short- and long-term antibiotic treatment reduces airway and systemic inflammation in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2012 Oct 1;186(7):657-65. doi: 10.1164/rccm.201203-0487OC. Epub 2012 Jun 28.'}, {'pmid': '20870753', 'type': 'DERIVED', 'citation': 'Murray MP, Govan JR, Doherty CJ, Simpson AJ, Wilkinson TS, Chalmers JD, Greening AP, Haslett C, Hill AT. A randomized controlled trial of nebulized gentamicin in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2011 Feb 15;183(4):491-9. doi: 10.1164/rccm.201005-0756OC. Epub 2010 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise capacity and health related quality of life with a reduction in exacerbation frequency and health care utilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bronchiectasis confirmed by HRCT of the chest\n* Clinically stable (not requiring antibiotics for at least 4 weeks preceding the study start date)\n* Aged 18-70\n* Chronic sputum production \\> 5 mls for the majority of days in 3 months before enrolment\n* Chronically colonized (on at least 2 occasions in the preceding 12 months) whilst clinically stable\n* At least two exacerbations in the past year\n* Patients able to tolerate a nebulized gentamicin challenge\n* FEV1 \\> 30% predicted\n* Smoking \\< 20 pack year history and ex-smokers \\>1 year.\n\nExclusion Criteria:\n\n* Cystic fibrosis\n* Emphysema on HRCT chest\n* Thoracic surgery within the past 1 year\n* Allergic bronchopulmonary aspergillosis\n* Poorly controlled asthma ( \\> 20% diurnal variation in peak expiratory flows despite treatment)\n* Unstable angina or uncontrolled congestive cardiac failure\n* Active malignancy\n* Pregnancy or breast feeding\n* Creatinine clearance \\< 30 mls/minute\n* Vestibular instability\n* Previous documented intolerance to aminoglycosides'}, 'identificationModule': {'nctId': 'NCT00749866', 'briefTitle': 'Long Term Nebulised Gentamicin in Patients With Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis', 'orgStudyIdInfo': {'id': 'CZB/4/451'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Nebulised Gentamicin', 'interventionNames': ['Drug: Gentamicin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Nebulised 0.9% Saline', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Gentamicin', 'type': 'DRUG', 'description': 'Nebulised 80mg twice daily', 'armGroupLabels': ['1']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Nebulised 4mls 0.9% Saline twice daily', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SA', 'city': 'Edinburgh', 'state': 'Lothian', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Adam T Hill, MBChB MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Lothian and University of Edinburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Lothian', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Dr Adam Hill; Consultant Physician and Honorary Senior Lecturer', 'oldOrganization': 'NHS Lothian and University of Edinburgh'}}}}