Status:
COMPLETED
Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study
Lead Sponsor:
The George Institute
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief 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 (Chr...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2018
Estimated Enrollment :
1670 Patients enrolled
Trial Details
Trial ID
NCT02261727
Start Date
June 1 2014
End Date
May 14 2018
Last Update
August 12 2021
Active Locations (1)
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1
The George Institute for Global Health
Sydney, New South Wales, Australia, 2000