Extrait

Background and study aims Chronic Obstructive Pulmonary Disease (COPD) is a lung disease that causes obstruction of the airflow. In the UK, it affects around 3 million people. It is the fifth leading cause of death and costs the NHS about £1 billion each year. Recommended treatment for COPD includes inhaled corticosteroids (ICS) to reduce worsening of symptoms and improve lung function. However, this is not very effective and even high doses fail to prevent worsening of the disease. Research shows that low dose theophylline may be effective, and when used with ICS will reduce worsening of the disease. In this study we will find out the clinical and cost effectiveness of adding low dose theophylline to ICS therapy in patients with COPD. Who can participate? We will recruit male and female patients aged 40 and over, who have COPD, who are taking inhaled corticosteroids and who have had two or more instances of worsening of symptoms in the previous year. What does the study involve? After they have agreed to take part, participants will be randomly allocated to receive either theophylline or placebo (dummy) for 12 months. We will follow up participants at six and 12 months to assess the number of occurrences of worsening of symptoms. We will also collect information on side effects, usage of the available health care, quality of life and breathlessness, and lung function. What are the possible benefits and risks of participating? Higher doses of theophylline have been used for more than 70 years to treat asthma and COPD. Side effects (such as anxiety, sleeplessness, dizziness, headache, rapid heart beat, upset stomach, rash, urine retention) can occur. It is estimated that at a low dose (as will be used in our study), less than 5% of participants will experience side effects. Participants who receive the theophylline may benefit as a result of receiving this drug because the risk of worsening may be less than without the drug. Participants who receive placebo may benefit because of evidence that participation in a clinical study improves the condition possibly due to better adherence to the background therapy. Where is the study run from? We will recruit participants from GP surgeries and hospitals across seven areas of the UK (Grampian, Glasgow, Newcastle, Hull, Liverpool, Birmingham and East Anglia). When is the study starting and how long is it expected to run for? Recruitment starts in September 2013 and is expected to be completed by August 2015. Follow-up within the study will be completed by September 2016. The study will report its findings in 2017. Who is funding the study? The study is funded by the National Institute for Health Research (NIHR), UK. Who is the main contact? The TWICS study office Tel: +44 (0)1224 438178 Email: [email protected]

Critère d'inclusion

• Topic: Primary Care Research Network for England, Respiratory; Subtopic: Not Assigned, Respiratory (all Subtopics); Disease: Respiratory, All Diseases

Liens

• isrctn
• ictrp