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Effects of Low-Dose Theophylline During Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00671151
First Posted: May 5, 2008
Last Update Posted: May 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fondo de Investigación Sanitaria (FIS)
Sociedad Española de Neumología y Cirugía Torácica
Information provided by:
Hospital Universitari Son Dureta
  Purpose
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
COPD Drug: Theophylline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Molecular Mechanisms of COPD Exacerbations. Effect of Low-Dose Theophylline

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Son Dureta:

Primary Outcome Measures:
  • HDAC activity in alveolar macrophages [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Lung function [ Time Frame: 3 months ]
  • Inflammatory cytokine release in sputum and serum [ Time Frame: 3 months ]

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
Active Comparator: 1
Low-dose theophylline on top of standard therapy for COPD exacerbation
Drug: Theophylline
Theophylline 100 mg bid for 3 months
No Intervention: 2
Standard therapy for COPD exacerbation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Severe COPD according to GOLD guidelines
  • Age between 40 and 75
  • Admission to hospital due to COPD exacerbation

Exclusion Criteria:

  • History of asthma
  • Pulmonary embolism
  • Pneumonia
  • Other chronic inflammatory disease
  • Patient on theophylline at the time of admission
  • Patient on oral steroids at the time of admission
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671151


Locations
Spain
Hospital Universitario Son Dureta
Palma de Mallorca, Baleares, Spain, 07014
Sponsors and Collaborators
Hospital Universitari Son Dureta
Fondo de Investigación Sanitaria (FIS)
Sociedad Española de Neumología y Cirugía Torácica
Investigators
Principal Investigator: Borja G Cosio, MD Hospital Universitario Son Dureta
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Borja G Cosio MD, Specialist in Respiratory Medicine
ClinicalTrials.gov Identifier: NCT00671151     History of Changes
Other Study ID Numbers: FIS042146
First Submitted: April 30, 2008
First Posted: May 5, 2008
Last Update Posted: May 5, 2008
Last Verified: April 2008

Keywords provided by Hospital Universitari Son Dureta:
COPD exacerbation
histone
steroid resistance
inflammation
theophylline

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Theophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents