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Low-dose Theophylline as Anti-inflammatory Enhancer in Severe Chronic Obstructive Pulmonary Disease

NCT01599871 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-08-29

No results posted yet for this study

Summary

The main objective of the study is to determine the effects of low-dose oral theophylline added to combination treatment with long-acting β-agonist (LABA) and inhaled corticosteroid (ICS) in patients with severe Chronic Obstructive Pulmonary Disease (COPD) on the rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation.

DESIGN: Phase III multicenter, randomized, placebo-controlled, double blind, parallel, prospective study. Patient will be recruited during an hospitalisation due to COPD exacerbation and randomised at the time of discharge to receive theophylline 100 mg or placebo on top of combination therapy with inhaled corticosteroids and long-acting beta agonist. The rate of exacerbations will be determined every three months up to one year follow-up. Cl inic visits: every 3 months (total number of clinic visits = 4). In each of them, the following information will be obtained:

* Number/severity of exacerbations or hospitalisation since last clinic visit
* Compliance and side effects
* Blood sample
* Plasma levels of theophylline
* Sputum (induced)
* MMRC
* SGRQ
* Forced spirometry + inspiratory capacity

\- At the beginning and at the end of the study
* 6MWT
* BMI
* BODE

Conditions

Interventions

DRUG

theophylline

theophylline 100 mg, twice at day

OTHER

placebo

Placebo

Sponsors & Collaborators

  • Spanish Research Center for Respiratory Diseases

    collaborator OTHER

  • Fundación Mutua Madrileña

    collaborator OTHER

  • Hospital Son Espases

    lead OTHER

Principal Investigators

  • Borja G Cosio, MD · Hospital Son Espases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-12-31
Completion
2016-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01599871 on ClinicalTrials.gov