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

Sponsor
Hospital Universitari Son Dureta (Other)
Overall Status
Completed
CT.gov ID
NCT00671151
Collaborator
Fondo de Investigación Sanitaria (FIS) (Other), Sociedad Española de Neumología y Cirugía Torácica (Other)
35
Enrollment
1
Location
2
Arms
30
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
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
Study Start Date :
Jun 1, 2005
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. HDAC activity in alveolar macrophages [3 months]

Secondary Outcome Measures

  1. Lung function [3 months]

  2. Inflammatory cytokine release in sputum and serum [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00671151
Other Study ID Numbers:
  • FIS042146
First Posted:
May 5, 2008
Last Update Posted:
May 5, 2008
Last Verified:
Apr 1, 2008
Keywords provided by , ,
COPD exacerbation
histone
steroid resistance
inflammation
theophylline
Additional relevant MeSH terms:
Theophylline

Study Results

No Results Posted as of May 5, 2008