Smoking Relapse Prevention Among COPD Ex-smokers

• Status: Terminated
• Trial end date: 2018-04-13
• Target enrollment: 0
• Participant gender: All

Summary

A placebo-controlled trial to determine whether recent ex-smokers with COPD who successfully stop smoking after taking varenicline are less likely to relapse back to smoking if they continue using varenicline for a further 12 weeks

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Auckland, New Zealand
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• Daily smokers

• Diagnosed with COPD (as per the Global Initiative for Chronic Obstructive Lung Disease [GOLD] criteria, namely: a characteristic clinical picture of dyspnea, cough or sputum, with a history of exposure to risk factors, plus a post-bronchodilator forced expiratory volume in one second / forced vital capacity FEV1/FVC ratio of <0.70)

• Have stable COPD (i.e. no exacerbation, hospital admission, or use of antibiotics or prednisone in the past six weeks)

• Can provide consent

• Reside in the Auckland region of New Zealand

• Eligible under New Zealand special authority to receive subsidised varenicline

• Prepared to make a quit attempt with varenicline

• Have access to a phone

Exclusion Criteria:

• A history of definite asthma and/or atopy

• Contraindications to varenicline

• Used varenicline in the past 12 months

• A history of serious psychiatric illness or significant cognitive impairment

• Major or uncontrolled co-morbidities (such as uncontrolled heart failure, infection or rapidly progressive condition)

• A life expectancy of < 12 months

• Are currently using another cessation medication (including e-cigarettes)