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

NCT ID: NCT00671151

Last Updated: 2008-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-12-31

Brief Summary

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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

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Conditions

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COPD

Keywords

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COPD exacerbation histone steroid resistance inflammation theophylline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Theophylline

Intervention Type DRUG

Theophylline 100 mg bid for 3 months

2

Standard therapy for COPD exacerbation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Theophylline

Theophylline 100 mg bid for 3 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fondo de Investigación Sanitaria (FIS)

UNKNOWN

Sponsor Role collaborator

Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role collaborator

Hospital Universitari Son Dureta

OTHER

Sponsor Role lead

Responsible Party

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Specialist in Respiratory Medicine

Principal Investigators

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Borja G Cosio, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Son Dureta

Locations

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Hospital Universitario Son Dureta

Palma de Mallorca, Balearic Islands, Spain

Site Status

Countries

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Spain

References

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Cosio BG, Tsaprouni L, Ito K, Jazrawi E, Adcock IM, Barnes PJ. Theophylline restores histone deacetylase activity and steroid responses in COPD macrophages. J Exp Med. 2004 Sep 6;200(5):689-95. doi: 10.1084/jem.20040416. Epub 2004 Aug 30.

Reference Type BACKGROUND
PMID: 15337792 (View on PubMed)

Cosio BG, Iglesias A, Rios A, Noguera A, Sala E, Ito K, Barnes PJ, Agusti A. Low-dose theophylline enhances the anti-inflammatory effects of steroids during exacerbations of COPD. Thorax. 2009 May;64(5):424-9. doi: 10.1136/thx.2008.103432. Epub 2009 Jan 21.

Reference Type DERIVED
PMID: 19158122 (View on PubMed)

Other Identifiers

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FIS042146

Identifier Type: -

Identifier Source: org_study_id