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)
Research questions
Among patients with chronic obstructive pulmonary disease (COPD):
- Main trial - 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, physiological and cellular lung health measures compared with quitting smoking without vaping and continuing to smoke?
- 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?
Background
Around 35% of patients with COPD smoke. Smoking cessation is the only known strategy that slows the accelerated decline in lung function in these patients, and although there are effective smoking cessation treatments over 80% return to smoking. ECs are commercially available products that many people have used successfully to stop smoking. However there remain some unanswered questions about their effectiveness and effects on the lungs.
The ECAL trial aims to find out whether electronic cigarette can help people with COPD to stop smoking, and how it compares to using nicotine replacement therapy. As part of the trial, we will also be conducting two additional sub-studies to look at how switching to an e-cigarette affects lung health and wellbeing.
Aims and objectives
- Main trial aims and objectives: To investigate the effectiveness and cost effectiveness of ECs as an aid to smoking cessation compared with combination NRT in patients with confirmed COPD.
- Lung health sub-study aims and objectives: To investigate the effect of switching from smoking to exclusive EC use on clinical, physiological and cellular lung health measures compared with (1) quitting smoking without vaping and (2) continuing to smoke in patients with COPD.
- Wellbeing sub-study aims and objectives: To investigate the effect of switching from smoking to exclusive EC use on anxiety, depression and social quality of life compared with (1) quitting smoking without vaping and (2) continuing to smoke in patients with COPD.
Methods
The trial will recruit 1250 people with COPD who will be randomly assigned a treatment, either:
- Intervention arm: Electronic Cigarettes (EC), or
- Comparator arm: Combination Nicotine Replacement Therapy (NRT)
The trial will be conducted in approximately 20 NHS sites across the UK (secondary/ primary/ community settings). Potential participants will be identified directly by participating research sites. Participating research sites may also utilise Patient Identification Centres (PIC) to identify potentially eligible patients.
Patients who are interested in the trial will undertake a pre-baseline check, to ensure they meet the minimum trial entry requirements and, if applicable, set up an appointment for the initial visit.
The initial visit (baseline) will be held at the participant's local research site. During this visit informed consent will be documented, screening is undertaken and participants will be asked to complete a questionnaire, give a blood sample and undertake lung function tests. Partcipants will also be allocated a treatment (either EC or combination NRT)
All trial particpants will receive standard stop smoking behavioural support through telephone calls from a trained smoking cessation advisor within a few days of their hospital appointment, on their planned quit day and after 1, 2, 3 and 4 weeks post quit day. At 4 weeks and 26 weeks, participants will be followed up by phone or post to complete a questionnaire. After 52 weeks, participants will return to their local research site to complete the final questionnaire, repeat the lung function tests and give another blood sample.
Trial outcomes will be analysed using regression analyses with economic analysis. We will report adverse and serious adverse events. Nested cohort analyses conducted in trial participants will re-group patients by smoking/vaping status, and compare changes in clinical lung health measures between the three exposure groups. This study will be powered to confirm if ECs are better than the best available treatment (combination NRT), and will enable investigation of the effect of EC on the lungs in a group of patients who are likely to be susceptible to any harmful effects. Anticipated impact and dissemination Findings of this research will be relevant to policy and practice recommendations for essential stakeholder groups including academia, healthcare professionals, industry, public health agencies (governmental and charity driven) and also importantly the lay public understanding of the effectiveness and safety of ECs. We will ensure wide dissemination through academic, health organisation and media channels.