ECAL trial
Research type
Research Study
Full title
Effectiveness of electronic cigarettes compared with combination nicotine replacement therapy for smoking cessation in patients with chronic obstructive pulmonary disease and effect on lung health (ECAL Trial).
IRAS ID
1006828
Contact name
David Thickett
Contact email
Sponsor organisation
University of Birmingham
Research summary
Chronic obstructive pulmonary disease (COPD) is a common lung condition which mainly affects adults aged 35 years and older, and it is most often caused by smoking. COPD symptoms tend to get gradually worse over time and can limit normal activities. Smoking speeds up the progression of COPD but it can be extremely hard to quit, and people with COPD tend to have a greater dependence on nicotine. There are several different treatments available that increase peoples chances of successfully quitting smoking; however, many people still relapse back to smoking. Electronic cigarettes (e-cigs) are not currently available on NHS prescription, but could help COPD patients to quit smoking. Our goal with this research is to find out how effective e-cigs are compared with combination NRT in helping COPD patients quit smoking cigarettes, and which treatment is more cost-effective for the NHS. The data collected during this trial will also be used to inform a lung health sub-study and wellbeing sub-study. The lung health sub-study will look at the effects of switching to vaping on clinical, physiological and cellular measures of lung health between vapers, continued smoker and quitters. The wellbeing sub-study will look at the effect of switching to vaping on anxiety, depression and social quality of life compared to those who smoke and quitters. This multi-centre trial will invite potentially eligible patients identified from selected GP practices and NHS hospitals in England, Wales and Scotland. This trial aims to recruit 1250 people aged 35 years and older, who have been diagnosed with COPD, and are current smokers who want to try to stop smoking. Trial participants will be followed up for 1 year. All participants will be asked to have two face-to-face clinic visits to undertake lung function tests and blood tests. Participants will also receive behaviour support calls from a smoking cessation advisor at set time points through the follow up period.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
23/NE/0102
Date of REC Opinion
3 Oct 2023
REC opinion
Further Information Favourable Opinion