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| ID | Type | Description | Link |
|---|---|---|---|
| RB 11-135 | Registry Identifier | RB 11-135 |
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Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the bronchi with an increasing prevalence. By 2020, the mortality related to COPD is expected to become the 3rd leading death worldwide. COPD is caused by smoking in approximately 90 % of the cases. Nevertheless, COPD remains under-diagnosed and more than half of patients remain active smokers. Brittany is the second region of France facing an abnormal high death rate related to COPD. Smoking cessation is the most effective therapeutic approach to reduce the evolution of the disease, the frequency of the exacerbations and the the mortality. Besides, smoking cessation is associated with a reduced risk of cardiovascular events and cancer. Given the COPD patients' strong addiction, smoking cessation is not easily obtained in such population. Furthermore, smoking cessation has been underestimated in several studies. Most of these studies evaluated various methods of smoking cessation in COPD patients performed after an exacerbation, which has a hospitalization related mortality of approximately 10%. Thus, there is an urgent need to find effective pharmacotherapies to help COPD patients to cease smoking. Varenicline, a partial agonist at a4ĂŸ2 nicotinic acetylcholine receptors is reported to be one of the most effective pharmacotherapies for smoking cessation. However, it has never been evaluated at the acute phase of an exacerbation of COPD requiring hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline with counselling | Experimental | Active varenicline associated with intensive smoking cessation counselling |
|
| Placebo with counselling | Placebo Comparator | Placebo of varenicline associated with intensive smoking cessation counselling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate an increase in smoking abstinence rate | To demonstrate that in smokers with COPD hospitalized for an exacerbation early initiation of a pharmacotherapy by varenicline during 12 weeks is associated with a higher rate of long-term smoking abstinence measured in 1 year compared to placebo. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the tolerance of the varenicline | Evaluate the side effects of varenicline after 3 months of treatment | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis COUTURAUD, Pr | University hospital of Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | France | 49933 | France | ||
| HĂ´pital HIA Clermont Tonnerre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34611902 | Derived | Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4. | |
| 31854207 | Derived | Le Mao R, Tromeur C, Paleiron N, Sanchez O, Gagnadoux F, Jouneau S, Magnan A, Hayem-Vannimenus C, Dansou A, Proust A, Dion A, Larhantec G, Brestec AL, Dewitte JD, Roche N, Leroyer C, Couturaud F. Effect of Early Initiation of Varenicline on Smoking Cessation in COPD Patients Admitted for Exacerbation: The Save Randomized Clinical Trial. COPD. 2020 Feb;17(1):7-14. doi: 10.1080/15412555.2019.1703928. Epub 2019 Dec 19. |
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|
| Brest |
| France |
| 29200 |
| France |
| Cavale Blanche Hospital | Brest | France | 29609 | France |
| Laennec Hospital | Nantes | France | 44093 | France |
| Caremeau Hospital | Nîmes | France | 30029 | France |
| Hotel Dieu Hospital | Paris | France | 75004 | France |
| HEGP Hospital | Paris | France | 75015 | France |
| Poitiers Hospital | Poitiers | France | 86021 | France |
| Cornouaille Hospital | Quimper | France | 29107 | France |
| Pontchaillou | Rennes | France | 35033 | France |
| Saint Brieuc Hospital | Saint-Brieuc | France | 22027 | France |
| Bretonneau Hospital | Tours | France | 37044 | France |
| CHRU Lille | Lille | 59037 | France |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| 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 |
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
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