Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT00147667
Status:
UNKNOWN
Last Update Posted:
2005-09-07
First Post:
2005-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD
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': 'D004917', 'term': 'Erythromycin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-03', 'completionDateStruct': {'date': '2006-03'}, 'lastUpdateSubmitDate': '2005-09-02', 'studyFirstSubmitDate': '2005-09-02', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2005-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exacerbation Frequency'}, {'measure': 'Airway Inflammation'}], 'secondaryOutcomes': [{'measure': 'Lung Function'}, {'measure': 'Health Status'}, {'measure': 'Exacerbation Recovery Time'}, {'measure': 'Symptoms'}]}, 'conditionsModule': {'keywords': ['COPD', 'EXACERBATIONS', 'AIRWAY INFLAMMATION'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '18723437', 'type': 'DERIVED', 'citation': 'Seemungal TA, Wilkinson TM, Hurst JR, Perera WR, Sapsford RJ, Wedzicha JA. Long-term erythromycin therapy is associated with decreased chronic obstructive pulmonary disease exacerbations. Am J Respir Crit Care Med. 2008 Dec 1;178(11):1139-47. doi: 10.1164/rccm.200801-145OC. Epub 2008 Aug 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether long term treatment with oral erythromycin is effective in the treatment of subjects with Chronic Obstructive Pulmonary Disease (COPD) by reducing the number of exacerbations and the degree of airway inflammation.', 'detailedDescription': 'COPD is characterised by persisting airway inflammation which leads to a progressive and irreversible deterioration in lung function with the eventual development of respiratory symptoms which may become disabling. Periodic episodes of worsening symptoms or exacerbations are a major cause of additional morbidity, mortality and health care utilization. Currently available therapies have limited efficacy in reducing airway inflammation or preventing exacerbations.\n\nMacrolides such as erythromycin have been shown to have potent anti-inflammatory effects in in vitro experiments and in other lung conditions such as cystic fibrosis and bronchiectasis as well as in open label studies in COPD. We hypothesised that long term therapy with oral erythromycin would reduce airway inflammation and reduce the frequency of exacerbations in patients with COPD. If these properties are demonstrated this therapy can have potentially important benefits if effective in this condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical Diagnosis of COPD\n* Clinically stable for 6 weeks\n* Able to Swallow Tablets\n\nExclusion Criteria:\n\n* Clinically significant respiratory disease other than COPD\n* Women of child bearing age\n* Patients receiving existing Medication which may interact adversely with trial drug\n* History of clinically significant liver disease'}, 'identificationModule': {'nctId': 'NCT00147667', 'briefTitle': 'Effects of Long Term Macrolide Antibiotic Therapy in Patients With COPD', 'organization': {'class': 'OTHER', 'fullName': 'Royal Free and University College Medical School'}, 'officialTitle': 'Randomised Double Blind Placebo Controlled Trial of Effects of Long Term Low Dose Oral Erythromycin Therapy in Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'P03/03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Erythromycin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW3 1PF', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Jadwiga A Wedzicha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Free and University College Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Free and University College Medical School', 'class': 'OTHER'}}}}