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| ID | Type | Description | Link |
|---|---|---|---|
| CTN980-CHC-9015-027 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicotine sublingual tablets | Drug | |||
| low and high behavior support | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| smoking cessation after 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| smoking reduction after 12 months | ||
| change in quality of life (St. George Respiratory Questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Tønnesen, M.D., Ph.D. | Pulm. dept. Gentofte University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. pulm. medicine, Århus kommunehospital | Aarhus | Denmark | ||||
| Dept. pulm. medicine, Bispebjerg Hospital |
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| Copenhagen |
| Denmark |
| Dept of Pulm. medicine, Helsingør Sygehus | Elsinore | Denmark |
| Pulm. Dept., Frederiksberg Hospital | Frederiksberg, Copenhagen | Denmark |
| Pulm. Dept, Gentofte University Hospital | Hellerup | 2900 | Denmark |
| Dept. pulm. medicine, Nykøbing Falster Sygehus | Nykøbing Falster | Denmark |
| Pulm. dept, Odense University Hospital | Odense | Denmark |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D016540 | Smoking Cessation |
| D000074264 | Smoking Reduction |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015438 | Health Behavior |
| D012816 | Signs and Symptoms |
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