COPD, Smoking
Conditions
Keywords
smoking cessation, nicotine sublingual tablets, behaviour support, smoking reduction, quality of life, COPD, weight
Brief summary
This is a smoking cessation study with COPD patients where the researchers wanted to evaluate if nicotine sublingual tablets or placebo combined with low or high individual support could increase ½ and 1 year quit rates.
Detailed description
Placebo, controlled, randomized, double-blind trial with 400-1000 smoking COPD patients with FEV-1 \< 90 % predicted normal with the use of nicotine sublingual nicotine tablets or placebo for 12 weeks combined with individual clinic visits with low or high intensity conducted by trained nurses in several centres in pulmonary clinics in Denmark. Outcome was smoking cessation and smoking reduction after ½ and 1 year as self declared smoking status confirmed by carbon monoxide in expired air\< 10 ppm. Secondary outcomes were change in body-weight, quality of life (SF-36 and SGRQ), symptoms, lung function, adverse events.
Interventions
DRUGnicotine sublingual tablets
BEHAVIORALlow and high behavior support
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COPD patients (FEV1/FVC\<70% and FEV1\<90 % predicted) * Smoking 1 cigarette daily or more * Willing to follow the protocol
Exclusion criteria
* Used NRT or bupropion the last week * Not able or willing to adhere to the protocol * Estimated survival \< 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| smoking cessation after 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| smoking reduction after 12 months | — |
| change in quality of life (St. George Respiratory Questionnaire) | — |
Countries
Denmark
Outcome results
None listed