Chronic Obstructive Pulmonary Disease, Smoking Cessation
Conditions
Brief summary
A placebo-controlled trial to determine whether recent ex-smokers with COPD who successfully stop smoking after taking varenicline are less likely to relapse back to smoking if they continue using varenicline for a further 12 weeks
Detailed description
Smoking remains the leading cause of Chronic Obstructive Pulmonary Disease (COPD), a leading cause of death and disability in New Zealand. COPD particularly affects indigenous Māori and Pacific people, given their higher rates of smoking. COPD patients tend to have a higher level of nicotine dependence and, as a result, often find quitting harder and are more likely to relapse back to smoking. A clinical trial (N=262) is planned in Auckland, New Zealand to determine whether extended varenicline treatment combined with behavioural support can prevent relapse back to smoking in recent ex-smokers with COPD. Smoking cessation and relapse prevention are the most cost-effective interventions available for COPD patients that smoke, irrespective of their disease stage. The trial has the potential to significantly improve the outcomes of this common and chronic health condition in New Zealand.
Interventions
DRUGVarenicline
Two 0.5mg tablets taken twice daily
BEHAVIORALBehavioural support
Consisting of the study-specific doctor delivering relapse prevention orientated behavioural support at the time of consultation, plus six 10-15 minute calls over the 12 weeks delivered by a research assistant.
DRUGPlacebo
Two 0.5mg tablets taken twice daily
Sponsors
University of Auckland, New Zealand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Daily smokers * Diagnosed with COPD (as per the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] criteria, namely: a characteristic clinical picture of dyspnea, cough or sputum, with a history of exposure to risk factors, plus a post-bronchodilator forced expiratory volume in one second / forced vital capacity FEV1/FVC ratio of \<0.70) * Have stable COPD (i.e. no exacerbation, hospital admission, or use of antibiotics or prednisone in the past six weeks) * Can provide consent * Reside in the Auckland region of New Zealand * Eligible under New Zealand special authority to receive subsidised varenicline * Prepared to make a quit attempt with varenicline * Have access to a phone
Exclusion criteria
* A history of definite asthma and/or atopy * Contraindications to varenicline * Used varenicline in the past 12 months * A history of serious psychiatric illness or significant cognitive impairment * Major or uncontrolled co-morbidities (such as uncontrolled heart failure, infection or rapidly progressive condition) * A life expectancy of \< 12 months * Are currently using another cessation medication (including e-cigarettes)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous abstinence | 12 weeks post-randomisation | Continuous (lapse-free) abstinence biochemically validated using a carbon monoxide reading of \<10 ppm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to relapse | 12 weeks post-randomisation | Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days. |
| Urge to smoke/cravings | 12 weeks post-randomisation | The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS). |
| Cigarette dependence | 12 weeks post-randomisation | Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence |
| Health-related quality of life | 12 weeks post-randomisation | Measured using the EQ-5D |
| Serious adverse events | 12 weeks post-randomisation | — |
| Continuous abstinence | 24 weeks post-randomisation | Biochemically validated continuous (lapse-free) abstinence |
| 7-day point prevalence abstinence | 12 weeks post-randomisation | Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff. |
| Time to lapse | 12 weeks post-randomisation | Time to first lapse, defined as time to first cigarette smoked (even a puff) |
| Cigarettes per day | 12 weeks post-randomisation | Cigarettes smoked per day, if returned to smoking |
| COPD exacerbations requiring hospitalisation | 12 weeks post-randomisation | The number of COPD exacerbations in the past 12 weeks, defined as a worsening of COPD respiratory symptoms that resulted in a course of antibiotics and/or oral steroids; or an unscheduled visit to GP, urgent care, Emergency Department or as an inpatient. Data will be validated against medical records using data linkage. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Question about use of other cessation products | 12 weeks post-randomisation | Questions will be asked about whether other cessation products were used and if so, what type. E-cigarettes will be considered a possible cessation product. |
| Questions asked about the use of other cessation products | 24 weeks post-randomisation | Questions will be asked about whether other cessation products were used and if so, what type. E-cigarettes will be considered a possible cessation product. |
| Question about medication compliance (pill count). | 12 weeks post-randomisation | Ask about how many of their allocated pills they took |
| Medication adherence (Script redeemed) | 12 weeks post-randomisation | Question asked about whether they redeemed their allocated script |
Countries
New Zealand
Outcome results
None listed