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

Hospital Universitari Son Dureta

Status: Completed

Conditions: COPD

Treatments: Drug: Theophylline

Study type: Interventional

Funder types: Other

Identifiers

NCT00671151

FIS042146

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: Male

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

35 participants in 2 patient groups

1

Active Comparator group

Description:

Low-dose theophylline on top of standard therapy for COPD exacerbation

Treatment:

Drug: Theophylline

2

No Intervention group

Description:

Standard therapy for COPD exacerbation