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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU Angers
Angers, France, France
Hôpital HIA Clermont Tonnerre
Brest, France, France
Cavale Blanche Hospital
Brest, France, France
Laennec Hospital
Nantes, France, France
Caremeau Hospital
Nîmes, France, France
Hotel Dieu Hospital
Paris, France, France
HEGP Hospital
Paris, France, France
Poitiers Hospital
Poitiers, France, France
Cornouaille Hospital
Quimper, France, France
Pontchaillou
Rennes, France, France
Start Date
August 1, 2012
Primary Completion Date
November 1, 2015
Completion Date
November 1, 2015
Last Updated
February 11, 2016
83
ACTUAL participants
Varenicline
DRUG
placebo
DRUG
Lead Sponsor
University Hospital, Brest
NCT07477600
NCT06372899
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05878769