Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

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.
    

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, COPD Assessment Test (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
    

Intervention name(s): Theophylline; Prednisone; Placebo (for prednisone); Placebo (for Theophylline)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor; Prednisone is an oral glucocorticosteroid which has anti-inflammatory properties; 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; One tablet twice daily in arm 1 (theophylline placebo 1 BD + prednisone placebo 1 once daily)
Other intervention name(s): Theophylline (100 mg twice a day); Prednisone (5mg once daily); cortisone; Prednisone placebo 1 tab once daily in arms 1 and 2; Theophylline placebo 1 tab twice daily
Intervention MeSH terms: Prednisone; Cortisone; Theophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Theophylline; Oral corticosteroids; COPD exacerbations