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Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study

NCT02261727 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1670

Last updated 2021-08-12

Study results available
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Summary

The aim of this multi-centre, double blind, randomised, controlled trial (DBRCT) is to assess the effect of low dose theophylline, singly and in combination with low dose oral prednisone, on COPD (Chronic Obstructive Pulmonary Disease) exacerbations, quality of life and secondary clinical outcomes compared with usual therapy and placebo over 48 weeks of treatment. 1670 symptomatic patients with COPD will be recruited in China for comparison of low dose theophylline versus placebo and low dose theophylline + low dose prednisone The primary end-point for this study is the annualised COPD exacerbation rate between the treatment groups. Secondary outcomes included time to first severe exacerbation requiring hospitalisation or death, health status, and pre- and post-bronchodilator spirometry.

Conditions

Interventions

DRUG

Theophylline

Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor

DRUG

Prednisone

Prednisone is an oral glucocorticosteroid which has anti-inflammatory properties

DRUG

Placebo (for prednisone)

* Arm 1 : Theophylline Placebo 1 tab twice daily and Prednisone placebo 1 tab once daily * Arm 2 : Theophylline 100mg 1 tab twice daily and Prednisone placebo 1 tab once daily

DRUG

Placebo (for Theophylline)

One tablet twice daily in arm 1 (theophylline placebo 1 BD + prednisone placebo 1 once daily)

Sponsors & Collaborators

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • The George Institute

    lead OTHER

Principal Investigators

  • Norbert Berend, MD · The George Institute

  • Christine R Jenkins, MD · The George Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2018-05-14
Completion
2018-05-14

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
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 NCT02261727 on ClinicalTrials.gov