Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-02 @ 4:21 AM
Study NCT ID:
NCT00671151
Status:
COMPLETED
Last Update Posted:
2008-05-05
First Post:
2008-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Low-Dose Theophylline During Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D007249', 'term': 'Inflammation'}], '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': 'D013806', 'term': 'Theophylline'}], '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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-02', 'studyFirstSubmitDate': '2008-04-30', 'studyFirstSubmitQcDate': '2008-05-02', 'lastUpdatePostDateStruct': {'date': '2008-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HDAC activity in alveolar macrophages', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Lung function', 'timeFrame': '3 months'}, {'measure': 'Inflammatory cytokine release in sputum and serum', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD exacerbation', 'histone', 'steroid resistance', 'inflammation', 'theophylline'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '15337792', 'type': 'BACKGROUND', 'citation': 'Cosio BG, Tsaprouni L, Ito K, Jazrawi E, Adcock IM, Barnes PJ. Theophylline restores histone deacetylase activity and steroid responses in COPD macrophages. J Exp Med. 2004 Sep 6;200(5):689-95. doi: 10.1084/jem.20040416. Epub 2004 Aug 30.'}, {'pmid': '19158122', 'type': 'DERIVED', 'citation': 'Cosio BG, Iglesias A, Rios A, Noguera A, Sala E, Ito K, Barnes PJ, Agusti A. Low-dose theophylline enhances the anti-inflammatory effects of steroids during exacerbations of COPD. Thorax. 2009 May;64(5):424-9. doi: 10.1136/thx.2008.103432. Epub 2009 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'Molecular mechanisms of COPD exacerbations and the modulating effect of low dose theophylline on that inflammation are elucidated in this project. NF-kappa B-dependent pathway and acetylation status of nuclear histones are to be studied.Design: controlled, prospective and randomized study with or without theophylline, a potent HDAC activator.Objectives: 1) To determine NF-kB activation, histone deacetylase (HDAC) and histone acetyl-transferase (HAT) activity in sputum macrophages and blood monocytes during an episode of exacerbation and 3 months later, once stability is achieved. To correlate these measurements with inflammatory and oxidative stress markers and with pulmonary function and clinical variables. 2) To assess the effect of theophylline on previous molecular, functional and clinical data. Method: 25 patients with COPD will be recruited during an episode of exacerbation requiring hospitalization. NF-kB activation, HDAC and HAT activity, markers of inflammation and oxidative stress will be determined with specific assays. These determinations will be repeated once the patient is stable and compared with smokers and non smoker controls with normal lung function'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe COPD according to GOLD guidelines\n* Age between 40 and 75\n* Admission to hospital due to COPD exacerbation\n\nExclusion Criteria:\n\n* History of asthma\n* Pulmonary embolism\n* Pneumonia\n* Other chronic inflammatory disease\n* Patient on theophylline at the time of admission\n* Patient on oral steroids at the time of admission'}, 'identificationModule': {'nctId': 'NCT00671151', 'briefTitle': 'Effects of Low-Dose Theophylline During Chronic Obstructive Pulmonary Disease (COPD) Exacerbations', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari Son Dureta'}, 'officialTitle': 'Molecular Mechanisms of COPD Exacerbations. Effect of Low-Dose Theophylline', 'orgStudyIdInfo': {'id': 'FIS042146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Low-dose theophylline on top of standard therapy for COPD exacerbation', 'interventionNames': ['Drug: Theophylline']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Standard therapy for COPD exacerbation'}], 'interventions': [{'name': 'Theophylline', 'type': 'DRUG', 'description': 'Theophylline 100 mg bid for 3 months', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07014', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Hospital Universitario Son Dureta', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}], 'overallOfficials': [{'name': 'Borja G Cosio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Son Dureta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari Son Dureta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondo de Investigación Sanitaria (FIS)', 'class': 'UNKNOWN'}, {'name': 'Sociedad Española de Neumología y Cirugía Torácica', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Borja G Cosio MD', 'oldOrganization': 'Specialist in Respiratory Medicine'}}}}