ECAL
Summary
Objectives: Among patients with chronic obstructive pulmonary disease (COPD):
Maind Trials - What is the effectiveness and cost effectiveness of e-cigarettes (ECs) compared with combination nicotine replacement therapy (NRT) as an aid to smoking cessation?
Lung Health Sub-Study* - What is the effect of switching from smoking to exclusive EC use on clinical, psychological and cellular lunk health measures compared with quitting smoking without vaping and continuing smoking?
Wellbeing Sub-Study* - What is the effect of switching from smoking to exclusive EC use on depression, anxiety and social quality of life compared with quitting smoking without vaping and continuing to smoke?
*Data collected during the main trial will be used to conduct embedded cohort analyses.
Participants will be individually randomised in a 1:1 ration to either:
Intervention arm (EC): an EC Starter kit + initial supply of e-liquid. Participants in the intervention arm will be offered weekly telephone behavioural support up to 4 weeks post quit.
Comparator arm (NRT): up to 12-week supply of cobination NRT (e.g. patch + fast acting NRT product). Participans in the comparator arm will also be offered weekly telephone behavioural support up to 4 weeks post quit.
For more information please click HERE for the full summary.
Sponsor - University of Birmingham
Recruitment End Date - 01/06/2025
Type of Study - PIC
RSI Points - 200
MSE Practices Only!
Practice Involvement
Search, screen and invite participants (via SMS or mail out).
Participants will respond directly to the study team.
Eligibility Criteria
Inclusion
COPD diagnosis confirmed by post-bronchodilator spirometry (FEV1/FVC <0.7), any GOLD stage.
Current smoker (>5 cigarettes per day).
Motivated to stop smoking.
Aged 35 or over.
Exclusion
Unable to perform a spirometry to a satisfactory standard (e.g. die to dementia, lack of teeth, lack of coordination or not having a good oral seal).
deemed as unsuitable to participate in the trial (e.g. terminal illness, unable to give informed consent).
Unable to participate in behaviour support calls.
Severe angina or unstable cardiovascular disease.
History of end stage kidney disease.
History of cirrhosis of the liver.
Currently taking NRT, buproppion, varenicline or using ECs to stop or reduce smoking.
Currently taking part in another trial of smoking cessation or COPD treatment/management.
COPD exacerbation or inpatient hospital stay within the last 8 weeks (invite back and re-assess after 8 weeks).
Contraindications to spirometry within the last 12 weeks - tuberculsis infection, cardiac infarction, retinal detachment, Pneumothorax or surgery on the chest, abdomen, brain, ears or eyes (invite back and re-assess after 12-weeks).