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

Not Applicable

Completed

• Conditions: COPD
• Interventions: Drug: Theophylline

• Registration Number: NCT00671151
• Lead Sponsor: Hospital Universitari Son Dureta

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-04
• Study First Submitted: 2008-04-30
• Study First Submitted QC: 2008-05-02
• Last Update Submitted: 2008-05-02
• Study First Posted: 2008-05-05
• Last Update Posted: 2008-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Theophylline	Low-dose theophylline on top of standard therapy for COPD exacerbation

Primary Outcome Measures

Name	Time	Method
HDAC activity in alveolar macrophages	3 months

Secondary Outcome Measures

Name	Time	Method
Lung function	3 months
Inflammatory cytokine release in sputum and serum	3 months

Trial Locations

Locations (1)

Hospital Universitario Son Dureta; 🇪🇸 Palma de Mallorca, Baleares, Spain