Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:46 AM
Study NCT ID:
NCT00132860
Status:
UNKNOWN
Last Update Posted:
2005-10-19
First Post:
2005-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'completionDateStruct': {'date': '2007-12'}, 'lastUpdateSubmitDate': '2005-10-18', 'studyFirstSubmitDate': '2005-08-19', 'studyFirstSubmitQcDate': '2005-08-19', 'lastUpdatePostDateStruct': {'date': '2005-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in postbronchodilator FEV1'}], 'secondaryOutcomes': [{'measure': 'number of hospital admissions and number of hospital days'}, {'measure': 'mortality'}, {'measure': 'quality of life'}, {'measure': 'use of medication'}, {'measure': 'prevalence of respiratory pathogens'}, {'measure': 'prevalence of macrolide resistance'}, {'measure': 'inflammatory parameters'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '25908927', 'type': 'DERIVED', 'citation': 'Sorensen AK, Holmgaard DB, Mygind LH, Johansen J, Pedersen C. Neutrophil-to-lymphocyte ratio, calprotectin and YKL-40 in patients with chronic obstructive pulmonary disease: correlations and 5-year mortality - a cohort study. J Inflamm (Lond). 2015 Mar 18;12:20. doi: 10.1186/s12950-015-0064-5. eCollection 2015.'}, {'pmid': '24373580', 'type': 'DERIVED', 'citation': 'Holmgaard DB, Mygind LH, Titlestad IL, Madsen H, Pedersen SS, Johansen JS, Pedersen C. Plasma YKL-40 and all-cause mortality in patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2013 Dec 30;13:77. doi: 10.1186/1471-2466-13-77.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate, in patients with moderate to severe chronic obstructive lung disease, whether intermittent antibiotic treatment leads to:\n\n* A slower rate of decline in forced expiratory volume in one second (FEV1);\n* A reduction in the frequency and severity of exacerbations;\n* Fewer hospital admissions for chronic obstructive pulmonary disease (COPD);\n* Lower mortality;\n* An improved quality of life as compared to a group of placebo treated patients.', 'detailedDescription': 'Study Population: Patients with moderate to severe chronic obstructive lung disease.\n\nTrial Phase: IV\n\nStudy Design: Prospective, randomised, double-blind, placebo- controlled clinical trial.\n\nStudy Medicine: Azithromycin.\n\nDrug Administration: Oral.\n\nDrug Dose: 500 mg once daily for 3 days every month.\n\nDuration of Treatment: 3 years\n\nNumber of Evaluable Patients: 200 per treatment arm\n\nNumber of Included Patients: 400 per treatment arm, 800 patients in total.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients above 50 years of age, with a current admission for exacerbation of COLD or at least one admission within the previous two years.\n* Current or ex-smoker\n* Postbronchodilator FEV1 \\< 60% in stable condition (\\> 4 weeks after hospitalisation)\n* \\< 300 ml bronchodilator reversibility in FEV1\n\nExclusion Criteria:\n\n* Patients with end-stage COLD, who are not expected to survive for 3 years (typically bedridden patients being dyspnoeic in rest).\n* Patients with known other respiratory tract infection, e.g. tuberculosis or aspergillosis, in whom the intervention is known to be inefficient.\n* Patients with pulmonary malignancy\n* Patients with other pulmonary diseases than COLD.\n* Patients with immunodeficiency. However, COLD patients treated with steroids can be included.\n* Patients with known hereditary disposition to lung infections such as alfa-1-antitrypsin deficiency, cystic fibrosis or primary ciliary dyskinesia.\n* Patients receiving longterm antibiotic treatment ( e.g. recurrent cystitis).\n* Patients with known allergy or intolerance to azithromycin\n* Pregnant or breastfeeding women\n* Manifest heart, liver or renal insufficiency\n* Patients that, for reasons not stated above, are unlikely to be able to participate in a study period of 3 years.'}, 'identificationModule': {'nctId': 'NCT00132860', 'briefTitle': 'Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease: A Prospective, Randomized, Double-Blind Placebo-Controlled Study of Intermittent, Prophylactic Antibiotic Treatment With Azithromycin', 'orgStudyIdInfo': {'id': 'ProToCOL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'azithromycin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000 C', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Svend S Pedersen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}}}}