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NCT Number: NCT02261727

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The George Institute for Global Health

Sydney, New South Wales, 2000, Australia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Theophylline

Drug

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

Other names: Theophylline (100 mg twice a day)

Prednisone

Drug

Prednisone is an oral glucocorticosteroid which has anti-inflammatory properties

Other names: Prednisone (5mg once daily), cortisone

Placebo (for prednisone)

Drug
  • 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

Other names: Prednisone placebo 1 tab once daily in arms 1 and 2

Placebo (for Theophylline)

Drug

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

Other names: Theophylline placebo 1 tab twice daily

Primary outcomes

  1. Total COPD Exacerbation Rate

    Time frame: 48 weeks observation; rate annualised

    The total number of COPD exacerbations reported within 48 weeks

Secondary outcomes

  1. Time to First COPD Exacerbation

    Time frame: Median time (days) from randomisation to first exacerbation over a 48 week period per participant

    The median time (days) from randomisation to first exacerbation per participant

  2. Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)

    Time frame: Change over 48 week study duration

    THe St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.

  3. Post Bronchodilator FEV1

    Time frame: Change at 48 weeks

    The change in post bronchodilator FEV1 from baseline to 48 weeks

  4. Change in COPD Assessment Test (CAT) Score

    Time frame: 48 weeks

    The COPD Assessment Test (CAT) is a patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dysnea, chest tighteness) on health status. The range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. The outcome measure is assessing the change in score from baseline to 48 weeks. A negative change denotes an improvement in health status.

Other outcomes

  1. Hospitalisations

    Time frame: 48 weeks

    The total number of hospitalisation events within 48 weeks

Sponsors and collaborators

Lead sponsor

The George Institute

Other

Collaborators

  • National Health and Medical Research Council, Australia

Registry information

Official study title

The Effect of Low-dose Corticosteroids and Theophylline on the Risk of Acute Exacerbations of COPD: the TASCS Randomised Clinical Trial

Acronym: TASCS

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 10, 2014
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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