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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Chronic Obstructive Pulmonary Disease, COPD Exacerbation, Smoking

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Trial Information

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


Inclusion Criteria:



- 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.

- Inclusion during hospitalization.

- Motivated to quit smoking

- Able to understand the information and give a written consent.

- Available for a follow-up of 1 year.

Exclusion Criteria:

- 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.

- Taken by psychotropic medicines

- Use of marijuana or other frorms of tobacco during the study.

- Use of other stimulant drugs (ephedrine, phenylephrine) or appetite suppressants
during the study.

- Life expectancy of ≤ 12-months (ex: patients affected by a chronic disease in
terminal phase).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To demonstrate an increase in smoking abstinence rate

Outcome Description:

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.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Francis COUTURAUD, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

University hospital of Brest

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

SAVE RB11-135

NCT ID:

NCT01694732

Start Date:

August 2012

Completion Date:

September 2015

Related Keywords:

  • Chronic Obstructive Pulmonary Disease
  • COPD Exacerbation
  • Smoking
  • Chronic obstructive pulmonary disease
  • Varenicline
  • Smoking cessation
  • Lung Diseases
  • Respiration Disorders
  • Pulmonary Disease, Chronic Obstructive
  • Smoking
  • Lung Diseases, Obstructive

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