Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT01176318
Status:
WITHDRAWN
Last Update Posted:
2019-06-19
First Post:
2010-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Erdosteine for Treatment of Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D003371', 'term': 'Cough'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C048498', 'term': 'erdosteine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'grant was withdrawn no financial support to conduct the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-17', 'studyFirstSubmitDate': '2010-08-04', 'studyFirstSubmitQcDate': '2010-08-05', 'lastUpdatePostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 hr cough recording', 'timeFrame': '5 days', 'description': 'The primary objective is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measureing differerrence in hourly cough rate from baseline (Day 0) and Day 5 of treatment, compared with standard care plus placebo'}], 'secondaryOutcomes': [{'measure': 'Quality of life questionnaire', 'timeFrame': '10 days', 'description': 'QOL questionnaire score,Compare differece in scores recorded at baseline (day 0) and day 10, compare the difference between erdosteine plus standard care with that of standard care plus placebo.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cough', 'exacerbation', 'quality of life'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': "This is a parallel group, double-blind, placebo controlled, multi-centre, randomised trial.\n\n60 patients to be included who are adult patients admitted to hospital with a clinical diagnosis of acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Acute exacerbation of COPD will be defined as sustained worsening of the patient's condition with an increase in cough and one or more of dyspnoea, sputum volume or sputum purulence, necessitating a change in regular medication.\n\nThe primary objective of this study is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measured from baseline (Day 0) and at Day 5 of treatment, compared with standard care plus placebo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/females aged between 40-80 years\n* Previous diagnosis of COPD\n* Acute exacerbation of COPD requiring treatment with antibiotics and/or corticosteroids\n* Symptoms of increased breathlessness, cough, sputum volume or sputum purulence\n* Acute exacerbation of COPD hospitalised within 24hrs of study participation.\n* On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion\n* Known history of cigarette smoking at least 10 pack yrs\n* Willing and able to comply with study procedures\n* Able to provide written informed consent to participate\n\nExclusion Criteria:\n\n* Acute exacerbation of COPD within 8 weeks prior to inclusion\n* Arterial blood gas on admission \\< pH 7.26\n* Currently on treatment with mucolytics\n* Patients suffering from post nasal drip, or gastro-oesophageal reflux disease\n* Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus\n* On long-term oxygen therapy\n* Known or suspected hypersensitivity to erdosteine'}, 'identificationModule': {'nctId': 'NCT01176318', 'briefTitle': 'Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Erdosteine for Treatment of Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hull University Teaching Hospitals NHS Trust'}, 'officialTitle': 'A Double Blind, Placebo Controlled Multicentre Study of the Effects of Standard Care Plus Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'Erd090908'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'erdosteine', 'description': 'standard care plus erdosteine for 10 days', 'interventionNames': ['Drug: Erdosteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Standard care for exacerbation of COPD plus placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Erdosteine', 'type': 'DRUG', 'otherNames': ['erdotin'], 'description': 'capsule 300mg twice daily for 10 days', 'armGroupLabels': ['erdosteine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo capsule, twice daily for 10 days', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU16 5JQ', 'city': 'Cottingham', 'state': 'East Yorkshire', 'country': 'United Kingdom', 'facility': 'Castle Hill Hospital', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}], 'overallOfficials': [{'name': 'Alyn H Morice, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hull and east Yorkshire NHS trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hull University Teaching Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Galen Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}