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).
- Conditions
- Chronic obstructive pulmonary disease (COPD)Respiratory
- Registration Number
- ISRCTN82413824
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 1250
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 or over
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method