Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Varenicline Associated With Intensive Counselling Versus Placebo of Varenicline Associated With Intensive Counselling on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease (COPD). A Multicenter Randomized Double-blind Trial
Brief Summary: 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 a4ß2 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.


Options:
A: Intervention Type: DRUG; Name: varenicline (CP-526,555); Assigned to Arm(s): N/A
B: Arm Label: INTERVENTION GROUP: MEDITERRANEAN DIET COUNSELING; Type: EXPERIMENTAL; Interventions: Behavioral: Mediterranean diet counseling | Arm Label: CONTROL GROUP: WITHOUT CHANGES IN DIET; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Mediterranean diet counseling; Assigned to Arm(s): INTERVENTION GROUP: MEDITERRANEAN DIET COUNSELING
C: Arm Label: varenicline with counselling; Type: EXPERIMENTAL; Interventions: Drug: Varenicline | Arm Label: Placebo with counselling; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): varenicline with counselling | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo with counselling
D: Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Smoking cessation | Arm Label: Simultaneous; Type: EXPERIMENTAL; Interventions: Behavioral: Weight gain prevention and smoking cessation | Arm Label: Sequential; Type: EXPERIMENTAL; Interventions: Behavioral: Weight gain prevention and smoking cessation | Intervention Type: BEHAVIORAL; Name: Weight gain prevention and smoking cessation; Assigned to Arm(s): Sequential, Simultaneous | Intervention Type: BEHAVIORAL; Name: Smoking cessation; Assigned to Arm(s): Control

Answer: C