Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT00969904
Status:
COMPLETED
Last Update Posted:
2012-07-03
First Post:
2009-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study to Assess the Effect of High Dose N-acetylcysteine (NAC) in Chronic Obstructive Pulmonary Disease (COPD) Patients
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': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-29', 'studyFirstSubmitDate': '2009-08-31', 'studyFirstSubmitQcDate': '2009-08-31', 'lastUpdatePostDateStruct': {'date': '2012-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effect of high dose NAC (1800 mg)on small airways by measuring the total and peripheral airway resistance calculated with CFD', 'timeFrame': 'at baseline, after 12 weeks of placebo and after 12 weeks of NAC'}, {'measure': 'To assess the effect of high dose NAC (1800 mg)on oxidative stress by measuring exhaled NO and oxidative stress markers in blood and EBC', 'timeFrame': 'at baseline, after 12 weeks of placebo and after 12 weeks of NAC.'}], 'secondaryOutcomes': [{'measure': 'To assess dynamic and static lung volumes by spirometry, body plethysmography and diffusion', 'timeFrame': 'will be assessed at all visits'}, {'measure': 'To assess quality of life by the SGRQ', 'timeFrame': 'will be assessed at all visits'}, {'measure': 'To assess the tolerability and safety of high dose NAC', 'timeFrame': 'all visits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '24293993', 'type': 'DERIVED', 'citation': 'De Backer J, Vos W, Van Holsbeke C, Vinchurkar S, Claes R, Parizel PM, De Backer W. Effect of high-dose N-acetylcysteine on airway geometry, inflammation, and oxidative stress in COPD patients. Int J Chron Obstruct Pulmon Dis. 2013;8:569-79. doi: 10.2147/COPD.S49307. Epub 2013 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'Studies suggest that N-acetylcysteine (NAC) potentially reduces inflammation and hyperinflation in patients with COPD.\n\nIn this pilot study the efficacy, safety and tolerability of high dose NAC in 12 patients with moderate COPD will be examined. These patients will receive a placebo for 12 weeks and NAC for 12 weeks in a dosage of 3 times 600 mg a day on top of their usual medication in a randomized crossover design. All subjects will be followed for 28 weeks.\n\nThe effect of high dose NAC on small airways will be assessed by measuring the total and peripheral airway resistance calculated with Computational Fluid Dynamics (CFD). The effect on oxidative stress will be assessed by measuring exhaled NO and specific markers (CRP, erythrocyte sedimentation rate, IL-6, 8-isoprostane, H2O2, TNF-alfa, glutathione, GPX, SOD and IL-8) in blood and Exhaled Breath Condensate (EBC). Dynamic and static lung volumes will be assessed by spirometry, body plethysmography and diffusion. Quality of life and symptoms will be assessed by the St George Respiratory Questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with documented COPD based on the following criteria:\n\n * Smoking history of at least 10 pack-years\n * Decreased Tiffeneau index (FEV1/(FVC \\< 0.70)\n2. Patients aged ≥ 40 years\n3. Patients who stopped smoking since more than 1 month\n4. Patients who present moderate COPD with an FEV1 between 50 and 80% of predicted (GOLD 2)\n5. Patients should be treated according to GOLD guidelines\n\nExclusion Criteria:\n\n1. Unstable patients who developed an exacerbation during the last 8 weeks\n2. Patients who are current smokers or stopped less than 1 month\n3. Patients who are allergic to acetylcysteine or to another element of the product\n4. Patients with phenylketonuria or an untreated active peptic ulcer\n5. Patients with any stage kidney and/or heart insufficiency or hypertension\n6. Patients already treated with NAC for more than 6 months or during the last 3 months\n7. Patients on continuous treatment with oral, inhalation, intravenous or intramuscular corticosteroids\n8. Patients who are pregnant or are breast-feeding\n9. Patients who are treated with orally administered cephalosporins\n10. Patients using supplements containing antioxidants as vitamins C or E'}, 'identificationModule': {'nctId': 'NCT00969904', 'briefTitle': 'Pilot Study to Assess the Effect of High Dose N-acetylcysteine (NAC) in Chronic Obstructive Pulmonary Disease (COPD) Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Double Blind, Randomized, Placebo-controlled, Two-way Crossover, Pilot Study to Assess the Effect of High Dose N-acetylcysteine on Small Airways and on Inflammation and Oxidative Stress in COPD Patients.', 'orgStudyIdInfo': {'id': 'PML_DOC_0804'}, 'secondaryIdInfos': [{'id': 'EC 8/40/128'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: N-acetylcysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'N-acetylcysteine', 'type': 'DRUG', 'description': '600 mg TID for 12 weeks', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo tablet TID for 12 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'University Hospital Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'overallOfficials': [{'name': 'Wilfried A De Backer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Wilfried De Backer', 'investigatorAffiliation': 'University Hospital, Antwerp'}}}}