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Sponsors and Collaborators: |
Hospital Universitari Son Dureta Fondo de Investigación Sanitaria (FIS) Sociedad Española de Neumología y Cirugía Torácica |
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Information provided by: | Hospital Universitari Son Dureta |
ClinicalTrials.gov Identifier: | NCT00671151 |
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
Condition | Intervention |
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COPD |
Drug: Theophylline |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment |
Official Title: | Molecular Mechanisms of COPD Exacerbations. Effect of Low-Dose Theophylline |
Enrollment: | 35 |
Study Start Date: | June 2005 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Low-dose theophylline on top of standard therapy for COPD exacerbation
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Drug: Theophylline
Theophylline 100 mg bid for 3 months
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2: No Intervention
Standard therapy for COPD exacerbation
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Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Spain, Baleares | |
Hospital Universitario Son Dureta | |
Palma de Mallorca, Baleares, Spain, 07014 |
Principal Investigator: | Borja G Cosio, MD | Hospital Universitario Son Dureta |
Responsible Party: | Specialist in Respiratory Medicine ( Borja G Cosio MD ) |
Study ID Numbers: | FIS042146 |
Study First Received: | April 30, 2008 |
Last Updated: | May 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00671151 |
Health Authority: | Spain: Ethics Committee |
COPD exacerbation histone steroid resistance inflammation theophylline |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Theophylline Inflammation Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Enzyme Inhibitors Cardiovascular Agents |
Pharmacologic Actions Phosphodiesterase Inhibitors Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |