Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-29 @ 10:45 PM
Study NCT ID:
NCT01032304
Status:
UNKNOWN
Last Update Posted:
2014-06-13
First Post:
2009-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-11-02', 'releaseDate': '2016-09-13'}, {'releaseDate': '2016-11-21', 'unreleaseDateUnknown': True}, {'resetDate': '2017-02-28', 'releaseDate': '2017-01-10'}, {'releaseDate': '2017-05-12', 'unreleaseDateUnknown': True}, {'resetDate': '2017-12-18', 'releaseDate': '2017-05-17'}, {'resetDate': '2018-02-07', 'releaseDate': '2018-02-06'}, {'resetDate': '2018-10-26', 'releaseDate': '2018-02-09'}], 'estimatedResultsFirstSubmitDate': '2016-09-13'}}, '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': 'C048498', 'term': 'erdosteine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 492}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-12', 'studyFirstSubmitDate': '2009-12-11', 'studyFirstSubmitQcDate': '2009-12-13', 'lastUpdatePostDateStruct': {'date': '2014-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of acute exacerbations', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'spirometry parameters', 'timeFrame': '12 months'}, {'measure': 'COPD symptoms', 'timeFrame': '12 months'}, {'measure': 'Quality of life', 'timeFrame': '12 months'}, {'measure': 'Safety and tolerability of erdosteine', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '29025888', 'type': 'DERIVED', 'citation': 'Dal Negro RW, Wedzicha JA, Iversen M, Fontana G, Page C, Cicero AF, Pozzi E, Calverley PMA; RESTORE group; RESTORE study. Effect of erdosteine on the rate and duration of COPD exacerbations: the RESTORE study. Eur Respir J. 2017 Oct 12;50(4):1700711. doi: 10.1183/13993003.00711-2017. Print 2017 Oct.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effect of erdosteine, compared to placebo, on exacerbation rate over a 12-month treatment period in patients with moderate-to-severe COPD. Moreover, the effects of erdosteine on pulmonary function parameters, clinical symptoms and quality of life, and the long-term safety of the drug will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD stage II-III GOLD\n* At least 2 exacerbations in the previous 2-12 months\n\nExclusion Criteria:\n\n* Acute exacerbations in the 2 months prior to enrolment\n* Diagnosis of asthma and/or other relevant lung diseases\n* COPD stage IV\n* Unstable concurrent diseases'}, 'identificationModule': {'nctId': 'NCT01032304', 'acronym': 'RESTORE', 'briefTitle': 'The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edmond Pharma'}, 'officialTitle': 'The Efficacy and Safety of Erdosteine in the Long-term Therapy of Chronic Obstructive Pulmonary Disease (COPD). A 12-month, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study', 'orgStudyIdInfo': {'id': 'ERD-01-08/EP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erdosteine', 'description': '600 mg/day for 12 months', 'interventionNames': ['Drug: Erdosteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo for 12 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Erdosteine', 'type': 'DRUG', 'description': 'One 300 mg capsule twice a day', 'armGroupLabels': ['Erdosteine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One capsule twice a day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Campus Gasthuisberg Dep.t Longfunctiemetingen', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '1463', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'ASMOH-MC "Sveti Panteleiomon"', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Clinic for emergency Medicine and Intensive care, Pneumology and Physiatry', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Clinic of Pulmonary Disease-Military Medical Academy', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Clinical of Pneumology and Physiatry', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'city': 'Havlìckuv Brod', 'country': 'Czechia', 'facility': 'Plicnì Ordinace'}, {'city': 'Moravský Krumlov', 'country': 'Czechia', 'facility': 'Poliklinica Moravsky Krumlov', 'geoPoint': {'lat': 49.04893, 'lon': 16.31169}}, {'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Department of Respiratory Medicine, Faculty Hospital', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '15900', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Lipa Centrum Nove Butovice', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Lerymed spol. s.r.o.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '79601', 'city': 'Prostějov', 'country': 'Czechia', 'facility': 'Plicnì Ambulance', 'geoPoint': {'lat': 49.47188, 'lon': 17.11184}}, {'city': 'Příbor', 'country': 'Czechia', 'facility': 'Plicnì M.I.O., spol. s.r.o.', 'geoPoint': {'lat': 49.64094, 'lon': 18.14499}}, {'zip': '38601', 'city': 'Strakonice', 'country': 'Czechia', 'facility': 'Plicnì Ordinace', 'geoPoint': {'lat': 49.26141, 'lon': 13.90237}}, {'zip': '66902', 'city': 'Znojmo', 'country': 'Czechia', 'facility': 'Nemonice Znojmo', 'geoPoint': {'lat': 48.8555, 'lon': 16.0488}}, {'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Department of Respiratory Diseases, Copenhagen University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'city': 'Paris', 'country': 'France', 'facility': 'Service de Pneumologie, Hopital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Service de Pneumologie, Hopital Bois-Guillaume', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Casatenovo', 'state': 'Lecco', 'country': 'Italy', 'facility': 'UOC Pneumologia Riabilitativa INRCA', 'geoPoint': {'lat': 45.69514, 'lon': 9.31338}}, {'city': 'Legnago', 'state': 'Verona', 'country': 'Italy', 'facility': 'UOC di Pneumologia-Ospedale Mater Salutis', 'geoPoint': {'lat': 45.19365, 'lon': 11.30227}}, {'city': 'Benevento', 'country': 'Italy', 'facility': 'Dip. 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