Phase 4
N=1,670
Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT02261727 ↗Enrolled (actual)
1,670
Serious AEs
16.2%
Results posted
Aug 2021
Primary outcome: Primary: Total COPD Exacerbation Rate — 1.00; 0.86; 0.89 Exacerbations per participant year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Theophylline (Drug); Prednisone (Drug); Placebo (for prednisone) (Drug); Placebo (for Theophylline) (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- The George Institute
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total COPD Exacerbation Rate |
1.00; 0.86; 0.89 | — |
| SECONDARY Time to First COPD Exacerbation |
137; 150; 151 | — |
| SECONDARY Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ) |
-4.95; -6.85; -6.48 | — |
| SECONDARY Post Bronchodilator FEV1 |
-0.02; -0.01; -0.02 | — |
| SECONDARY Change in COPD Assessment Test (CAT) Score |
-2.29; -2.77; -2.57 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Current or former smokers (> 10 pack years) or biomass exposure
- 40 - 80 years of age
- Clinical diagnosis of COPD
- Post-bronchodilator FEV1 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
Data sourced from ClinicalTrials.gov (NCT02261727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.