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

May 2, 2008 updated by: Hospital Universitari Son Dureta

Molecular Mechanisms of COPD Exacerbations. Effect of Low-Dose Theophylline

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Baleares
      • Palma de Mallorca, Baleares, Spain, 07014
        • Hospital Universitario Son Dureta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HDAC activity in alveolar macrophages
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Lung function
Time Frame: 3 months
3 months
Inflammatory cytokine release in sputum and serum
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Son Dureta

Collaborators

Sociedad Española de Neumología y Cirugía Torácica
Fondo de Investigación Sanitaria (FIS)

Investigators

  • Principal Investigator: Borja G Cosio, MD, Hospital Universitario Son Dureta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

April 30, 2008

First Submitted That Met QC Criteria

May 2, 2008

First Posted (Estimate)

May 5, 2008

Study Record Updates

Last Update Posted (Estimate)

May 5, 2008

Last Update Submitted That Met QC Criteria

May 2, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIS042146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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