Chronic obstructive pulmonary disease (COPD) Respiratory
Conditions
Interventions
Intervention arm: Electronic Cigarettes (EC) - At the baseline visit, participants will be given an EC starter pack and an initial supply of e-liquid (up to 20 mg nicotine/ml). Participants will be pr
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
35 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 07/01/2026: 1. COPD diagnosis confirmed by post-bronchodilator spirometry (FEV1/FVC <0.7), any GOLD stage 2. Current daily smoker 3. Willing to try to stop smoking using only allocated trial products 4. Aged 35 years or over Previous inclusion criteria: 1. COPD diagnosis previously confirmed by post-bronchodilator spirometry (FEV1/FVC <0.7), any GOLD stage 2. Current smoker (=5 cigarettes per day) 3. Motivated to stop smoking 4. Aged 35 years or over
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 07/01/2026: 1. Unable to perform spirometry to a satisfactory standard (e.g. due to dementia, lack of teeth, lack of coordination or not having a good oral seal) 2. Deemed as unsuitable to participate in the trial (e.g. terminal illness, unable to give informed consent) 3. Unable to participate in behaviour support calls 4. Severe angina or unstable cardiovascular disease 5. History of end stage kidney disease 6. History of cirrhosis of the liver 7. Currently taking part in another trial of smoking cessation or COPD treatment/management 8. Contraindications to spirometry within the last 12 weeks – tuberculosis infection, cardiac infarction, retinal detachment, Pneumothorax or surgery on the chest, abdomen, brain, ears or eyes (invite back and re-assess after 12 weeks) Previous exclusion criteria: 1. Unable to perform spirometry to a satisfactory standard (e.g. due to dementia, lack of teeth, lack of coordination or not having a good oral seal) 2. Deemed as unsuitable to participate in the trial (e.g. terminal illness, unable to give informed consent) 3. Unable to participate in behaviour support calls 4. Severe angina or unstable cardiovascular disease 5. History of end stage kidney disease 6. History of cirrhosis of the liver 7. Currently taking NRT, bupropion, varenicline or ECs to stop or reduce smoking 8. Currently taking part in another trial of smoking cessation or COPD treatment/management 9. COPD exacerbation or inpatient hospital stay within the last 8 weeks (invite back and re-assess after 8 weeks) 10. Contraindications to spirometry within the last 12 weeks – tuberculosis infection, cardiac infarction, retinal detachment or surgery on the chest, abdomen, brain, ears or eyes (invite back and re-assess after 12 weeks)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abstinence from smoking since target quit date (TQD) biochemically validated (exhaled CO<8ppm), defined in accordance with the Russell Standard. This will be measured with a questionnaire and exhaled carbon monoxide measurement at 52 weeks post-TQD | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Abstinence from smoking for at least 26 weeks biochemically validated (exhaled CO 50% reduction) from baseline to 52 weeks measured using a questionnaire, confirmed by reductions in expired CO readings at 52 weeks 6. Reduction in cigarettes smoked (self-report of any and > 50% reduction) from baseline to 26/52 weeks measured using a questionnaire 7. Continued use of the allocated product measured using a questionnaire at 4, 26 and 52 weeks 8. Withdrawal symptoms and urges to smoke (change from baseline to 1/2/3/4 week) measured using the mood and physical symptom scale (MPSS) 9. COPD Symptoms (change from baseline to 4/26/52 week) measured using COPD Assessment Test (CAT) and the Clinical COPD Questionnaire (CCQ) 10. Number of COPD exacerbations over the past 52 weeks (change from baseline to 52 weeks) measured using a questionnaire 11. Number of self-reported upper respiratory tract over the past 52 weeks (change from baseline to 52 weeks) measured using a questionnaire 12. Post bronchodilator spirometry (FEV1, FVC and MMEF change from baseline to 52 weeks). Forced Expiratory Volume in 1 Second (FEV1): The maximal volume of air that can be expired in the first second of a forced expiration from a position of full inspiration (measured in Litres (L) and also expressed as the % predicted for age, sex, height and race). Forced Vital Capacity (FVC): The maximal volume of air that can be expired during a forced and complete expiration from a position of full inspiration (measured in L and % predicted). Mean Mid-Expiratory Flow (MMEF): The average flow between 25% and 75% of the FVC manoeuvre (measured in L/sec and % predicted). Health economic outcomes: 1. Health-related quality of life (EQ-5D-5L) measured using a questionnaire change from baseline to 4/26/52 weeks 2. Use of healthcare resources and costs measured using a questionnaire at 26 and 52 weeks 3. Cost-effectiveness based on cost per quitter and cost per Quality-Adjusted Life-Year (QALY) at 52 weeks, and | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactBirmingham Clinical Trials Unit
Outcome results
None listed