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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Dept. pulm. medicine, Århus kommunehospital
Aarhus, Denmark
Dept. pulm. medicine, Bispebjerg Hospital
Copenhagen, Denmark
Dept of Pulm. medicine, Helsingør Sygehus
Elsinore, Denmark
Pulm. Dept., Frederiksberg Hospital
Frederiksberg, Copenhagen, Denmark
smoking cessation after 6 and 12 months
smoking reduction after 12 months
change in quality of life (St. George Respiratory Questionnaire)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pulm. Dept, Gentofte University Hospital
Hellerup, Denmark
Dept. pulm. medicine, Nykøbing Falster Sygehus
Nykøbing Falster, Denmark
Pulm. dept, Odense University Hospital
Odense, Denmark