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

Information source: The George Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Theophylline (Drug); Prednisone (Drug); Placebo (for prednisone) (Drug); Placebo (for Theophylline) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: The George Institute

Official(s) and/or principal investigator(s):
Norbert Berend, MD, Principal Investigator, Affiliation: The George Institute
Christine R Jenkins, MD, Principal Investigator, Affiliation: The George Institute


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. Approximately 2400 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 difference between the three treatment groups in

- COPD exacerbation rate

- Time to first severe exacerbation requiring hospitalisation or death

Clinical Details

Official title: Low Dose Corticosteroids and Theophylline in the Treatment of Chronic Obstructive Pulmonary Disease - the TASCS Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: COPD exacerbation rate

Secondary outcome:

Time to first COPD exacerbation

Quality of life measured by St. George's Respiratory Questionnaire (SGRQ)

Pre and post bronchodilator FEV1

Change in CAT score

Detailed description: The investigators hypothesise that patients with COPD will have beneficial responses to low dose theophylline and prednisone, superior to placebo and low dose theophylline alone, reflected by a range of clinical outcomes. The study aims to demonstrate that treatment with low dose oral prednisone and low dose, slow release theophylline compared to low dose, slow release theophylline only or placebo will reduce COPD exacerbations and improve a range of secondary outcomes including quality of life, CAT score, hospital admissions and lung function. Eligible participants will be randomised to one of three treatment arms in a DBRCT and will receive placebo OR low-dose theophylline (100 mg twice a day) OR low-dose theophylline 100 mg twice a day (BD) plus low-dose prednisone (5 mg once a day) Patients will be eligible for inclusion if all the following criteria are met:

- Current or former smokers (>10 pack years) or biomass exposure

- 40 - 80 years of age

- Clinical diagnosis of COPD

- Post-bronchodilator forced expiratory volume at one second (FEV1) <70% predicted

- Post bronchodilator FEV1/forced vital capacity (FVC) ratio<0. 7


Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.


Inclusion Criteria:

- Current or former smokers (> 10 pack years) or biomass exposure

- 40 - 80 years of age

- Clinical diagnosis of COPD

- Post-bronchodilator FEV1 < 70% predicted

- Post bronchodilator FEV1/FVC ratio < 0. 7

Exclusion Criteria:

- Life expectancy of less than 12 months

- Exacerbation or respiratory infection within 4 weeks prior to randomisation

- Patient is taking and requires maintenance oral corticosteroids

- Patient is on domiciliary oxygen

- There has been previous pulmonary resection

- Previous sensitivity to, or intolerance of theophylline

- Coexistent illness precluding participation in the study (epilepsy, chronic liver

disease, unstable cardiovascular disease, diabetes, active malignancy)

- Inability to complete quality of life questionnaire

- Concomitant major illness that would interfere with visits, assessments and follow-up

- Have evidence of chronic liver disease, or transaminase or gamma-glutamyltransferase

(GGT) elevation > 1. 5 x upper limit of normal (ULN)

- Random blood glucose level > 8mmol/L

- High chance in the view of the treating physician that the patient will not adhere to

study treatment and follow up

Locations and Contacts

The George Institute for Global Health, Sydney, New South Wales 2000, Australia; Recruiting
Christine R Jenkins, MD, Phone: +61413155111, Email: christine.jenkins@sydney.edu.au
Emma Heeley, PhD, Phone: +61406078144, Email: eheeley@georgeinstitute.org.au
Additional Information

Starting date: May 2014
Last updated: May 14, 2015

Page last updated: August 23, 2015

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