Efficacy of Varenicline on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease

NCT01694732 | Completed Phase 3 DMC

• 2 other identifiers: SAVE RB11-135RB 11-135
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 13

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.

Conditions

Chronic Obstructive Pulmonary Disease; COPD Exacerbation; Smoking

Keywords

Chronic obstructive pulmonary disease; Varenicline; Smoking cessation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Estimate the tolerance of the varenicline

  3 months

Study Arms (2)

varenicline with counselling

EXPERIMENTAL

Active varenicline associated with intensive smoking cessation counselling

Drug: Varenicline

Placebo with counselling

PLACEBO COMPARATOR

Placebo of varenicline associated with intensive smoking cessation counselling

Drug: placebo

Interventions

Varenicline DRUG

varenicline with counselling

placebo DRUG

Placebo with counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients smokers (= 10 cigarettes per day in the last year)
• Affected by a chronic obstructive pulmonary disease.
• Presenting a recent exacerbation having led to at least a 24-hour hospitalization in pneumology or intensive care unit.
• Motivated to quit smoking
• Able to understand the information and give a written consent.
• Available for a follow-up of 1 year.

You may not qualify if:

• Refusal or unable to consent.
• Unaffiliated or not entitled to the National Health Insurance Coverage.
• Absence of a chronic obstructive pulmonary disease according to the criteria ATS / ERS.
• presenting a contraindication to the pharmacotherapy (i.e. the active substance: tartrate of varénicline or one of the excipients)
• actively participating in other smoking cessation trials.
• Pregnancy: declared or planned in 14 months.
• breastfeeding.
• Women old enough to procreate without reliable contraception.
• History of anorexia nervosa or bulimia.
• History of a severe depression and having required a medicinal treatment in 5 years.
• History of 2 or several episodes of severe depression and having required a medicinal treatment.
• Personal or family History of suicide attempt.
• History or current presence of dementia, a bipolar disease, a psychosis, a panic attack.
• SGOT or SGPT \> 2 fold upper limit of normal, the hepatic cirrhosis, the acute hepatitis.
• Renal insufficiency (clearance of the creatinine \< 30 ml / min according to the formula of Cockcroft).

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (13)

CHU Angers

Angers, France, 49933, France

Location

Hôpital HIA Clermont Tonnerre

Brest, France, 29200, France

Location

Cavale Blanche Hospital

Brest, France, 29609, France

Location

Laennec Hospital

Nantes, France, 44093, France

Location

Caremeau Hospital

Nîmes, France, 30029, France

Location

Hotel Dieu Hospital

Paris, France, 75004, France

Location

HEGP Hospital

Paris, France, 75015, France

Location

Poitiers Hospital

Poitiers, France, 86021, France

Location

Cornouaille Hospital

Quimper, France, 29107, France

Location

Pontchaillou

Rennes, France, 35033, France

Location

Saint Brieuc Hospital

Saint-Brieuc, France, 22027, France

Location

Bretonneau Hospital

Tours, France, 37044, France

Location

CHRU Lille

Lille, 59037, France

Location

Related Publications (2)

• 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.

  PMID: 34611902 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.

  PMID: 31854207 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking; Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Francis COUTURAUD, Pr

  University hospital of Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 11, 2016

Record last verified: 2016-02

Locations

FR (13)