Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-27 @ 1:15 AM
Study NCT ID:
NCT00826566
Status:
WITHDRAWN
Last Update Posted:
2015-09-23
First Post:
2009-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-inflammatory Effects of Caffeine in Chronic Obstructive Pulmonary Disease (COPD) Subjects
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': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Suitable subjects could not be recruited within the estimated time frame.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2009-01-21', 'studyFirstSubmitQcDate': '2009-01-21', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentrations of C-reactive protein (CRP) and the cytokines TNF-a, IL-6, IL-8 and IL-10.', 'timeFrame': 'at the start and at the end of the intervention periods'}], 'secondaryOutcomes': [{'measure': 'Activation of poly-(ADP-ribose) polymerase (PARP)-1 activation and DNA repair in peripheral lymphocytes', 'timeFrame': 'at the start and the end of the intervention periods'}, {'measure': 'Oxidative stress markers in plasma such as PGF2alpha', 'timeFrame': 'at the start and the end of the intervention periods'}, {'measure': 'Plasma concentrations of caffeine and metabolites', 'timeFrame': 'at the start and the end of the interventions'}, {'measure': 'Gene transcription levels of cytokines, redox enzymes and other proteins involved in inflammatory and oxidative stress response', 'timeFrame': 'at the start and the end of the interventions'}, {'measure': 'Cytokine concentrations in whole blood after ex vivo stimulation with LPS', 'timeFrame': 'at the start and the end of the interventions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'caffeine', 'chronic systemic inflammation', 'oxidative stress', 'supplementation', 'stable COPD GOLD stage II with CRP levels ≥ 3 mg/l'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Nowadays it has become evident that a chronic systemic inflammation is present in patients suffering from chronic obstructive pulmonary disease (COPD).\n\nThe role of the nuclear enzyme poly(adenosine diphosphate-ribose)polymerase (PARP) as a key mediator within these systemic inflammatory processes as well as in COPD associated exercise intolerance and muscle weakness could recently been identified. The attenuating effect of dietary ingredients with PARP inhibiting activity on systemic inflammation was supported by data from in vitro and in vivo studies, from other groups as well as from our own lab. We identified several caffeine metabolites as potent inhibitors of the most abundant PARP-isoform PARP-1 in-vitro, in animal models as well as in ex-vivo experiments with whole blood from COPD patients.\n\nHowever, clinical data with respect to their anti-inflammatory effects in COPD patients are currently not available for none of these substances. Therefore, the current clinical pilot study is intended to establish for the first time clinical data (proof of principle) on the anti-inflammatory potential of caffeine metabolites.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD GOLD stage II (50% ≤ FEV1\\< 80%)\n* CRP plasma levels ≥ 3 mg/l\n* BMI \\> 20 kg/m2 and \\< 30 kg/m2\n* Diastolic blood pressure (DBP)=60-90 mmHg, Systolic blood pressure (SBP)=100 150 mmHg\n\nExclusion Criteria:\n\n* Physical and/or mental disease or major surgery in the present or the past that might limit participation in or completion of the study\n* Reported current or previous metabolic (e.g. diabetes), cardiovascular and/or renal diseases\n* Known presence of a carcinoma\n* Acute and/or chronic inflammatory condition such as arthritis, arthrosis, chronic colitis, etc. during three months before entry of the study\n* Respiratory tract infection or exacerbation of COPD for at least 8 weeks prior to the start of the study\n* Change in treatment regime of the COPD subjects for at least 8 weeks prior to the start of the study\n* Use of laxatives, anti-diarrhoeal drugs and any other medication that can influence the uptake of the investigational products and/or influence their metabolism during the trial\n* During the month prior to the start of the study and during the study the use of antibiotics and/or local and systemic steroidal (glucocorticoids) and non-steroidal anti-inflammatory drugs (NSAID)\n* Abnormal constant dietary eating habits and a coffee consumption of less than 3 cups per day (i.e. a usual daily intake of \\<400 mg caffeine).'}, 'identificationModule': {'nctId': 'NCT00826566', 'briefTitle': 'Anti-inflammatory Effects of Caffeine in Chronic Obstructive Pulmonary Disease (COPD) Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Pilot Study to Investigate the Anti-inflammatory Effects of Caffeine in Subjects With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'STW6041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '500 mg caffeine capsules per day', 'interventionNames': ['Dietary Supplement: Caffeine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': '500 mg placebo capsules', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Caffeine', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 times 250 mg caffeine per day', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 times 250 mg per day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200 MD', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Centre (UMC+)', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Geja J Hageman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Health Risk Analysis and Toxicology, UMC+, Maastricht, The Netherlands'}, {'name': 'Antje R Weseler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Pharmacology & Toxicology, UMC+, Maastricht, The Netherlands'}, {'name': 'Aalt Bast, PhD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept. of Pharmacology & Toxicology, UMC+, Maastricht, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technologiestichting STW (NWO)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}