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TWICS - Theophylline with Inhaled CorticoSteroids

Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung disease affecting approximately 3 million people in the UK.  It is the fifth leading cause of death in the UK and costs the NHS approximately £1 billion annually.  Exacerbations of COPD are associated with accelerated rate of lung function decline, reduced physical activity, reduced quality of life, increased mortality and increased risk of other illnesses such as acute myocardial infarction and stroke. 

Usual treatment for COPD is inhaled corticosteroids.  Small studies have shown that giving patients theophylline at a low dose can increase the sensitivity of their airway to the effects of inhaled corticosteroids – and thus make the inhaled corticosteroids work better. 

In the TWICS study, we aim to determine whether adding low dose oral theophylline to inhaled corticosteroid therapy in patients with COPD reduces the risk of exacerbation, is cost effective to the NHS, improves quality of life and lung function and reduces mortality.  To do this, we will compare the effects of low dose theophylline against the effects of a placebo ‘dummy treatment’, which looks like the genuine medicine but contains no active ingredient.

We will invite people with COPD to take part in our study.  If they agree, we will allocate them to receive low-dose theophylline or placebo for 12 months.  Half of the participants in the study will take low-dose theophylline and half of the participants will take placebo.  We aim to recruit 1424 people with COPD into our study.

We will follow-up study participants after 6 and 12 months to find out how they are getting on and whether they have had any exacerbations of their COPD.   A summary of the study can be found here.  You can read more about the study here

Analysis of the study results is ongoing and we will report results in 2018.

The final data cut for analysis was taken on 22 November 2017. 

Staff at research sites can no longer amend or enter data on the study website (log-ons have been disabled) - please contact the trial office (twics@abdn.ac.uk) with any corrections to data or additional data. 

 

General Data Protection Regulation (GDPR) 
Participant Information

University of Aberdeen/NHS Grampian is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. University of Aberdeen/NHS Grampian will keep identifiable information about you at least 15 years after the study has finished. 

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information https://www.abdn.ac.uk/about/privacy/

 

 


The Health Services Research Unit is funded by the Chief Scientists Office of the Scottish Government Health and Social Care Directorates