Smoking Relapse Prevention Among COPD Ex-smokers (SPACE)

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

Study Overview

• Status: Terminated
• Conditions: Smoking Cessation; Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Varenicline; Behavioral: Behavioural support; Drug: Placebo

Detailed Description

Smoking remains the leading cause of Chronic Obstructive Pulmonary Disease (COPD), a leading cause of death and disability in New Zealand. COPD particularly affects indigenous Māori and Pacific people, given their higher rates of smoking. COPD patients tend to have a higher level of nicotine dependence and, as a result, often find quitting harder and are more likely to relapse back to smoking. A clinical trial (N=262) is planned in Auckland, New Zealand to determine whether extended varenicline treatment combined with behavioural support can prevent relapse back to smoking in recent ex-smokers with COPD. Smoking cessation and relapse prevention are the most cost-effective interventions available for COPD patients that smoke, irrespective of their disease stage. The trial has the potential to significantly improve the outcomes of this common and chronic health condition in New Zealand.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 3

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • National Institute for Health Innovation, University of Auckland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Varenicline plus behavioural support; 12 weeks extended treatment with varenicline, plus relapse prevention-orientated behavioural support	Drug: Varenicline; Two 0.5mg tablets taken twice daily; Other Names: Champix; Behavioral: Behavioural support; Consisting of the study-specific doctor delivering relapse prevention orientated behavioural support at the time of consultation, plus six 10-15 minute calls over the 12 weeks delivered by a research assistant.
Placebo Comparator: Placebo plus behavioural support; 12 weeks extended treatment with placebo, plus relapse prevention-orientated behavioural support	Behavioral: Behavioural support; Consisting of the study-specific doctor delivering relapse prevention orientated behavioural support at the time of consultation, plus six 10-15 minute calls over the 12 weeks delivered by a research assistant.; Drug: Placebo; Two 0.5mg tablets taken twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous abstinence	Continuous (lapse-free) abstinence biochemically validated using a carbon monoxide reading of <10 ppm.	12 weeks post-randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous abstinence	Biochemically validated continuous (lapse-free) abstinence	24 weeks post-randomisation
7-day point prevalence abstinence	Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff.	12 weeks post-randomisation
7-day point prevalence abstinence	Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff.	24 weeks post-randomisation
Time to lapse	Time to first lapse, defined as time to first cigarette smoked (even a puff)	12 weeks post-randomisation
Time to lapse	Time to first lapse, defined as time to first cigarette smoked (even a puff)	24 weeks post-randomisation
Time to relapse	Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.	12 weeks post-randomisation
Time to relapse	Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.	24 weeks post-randomisation
Cigarettes per day	Cigarettes smoked per day, if returned to smoking	12 weeks post-randomisation
Cigarettes per day	Cigarettes smoked per day, if returned to smoking	24 weeks post-randomisation
COPD exacerbations requiring hospitalisation	The number of COPD exacerbations in the past 12 weeks, defined as a worsening of COPD respiratory symptoms that resulted in a course of antibiotics and/or oral steroids; or an unscheduled visit to GP, urgent care, Emergency Department or as an inpatient. Data will be validated against medical records using data linkage.	12 weeks post-randomisation
COPD exacerbations requiring hospitalisation	The number of COPD exacerbations in the past 12 weeks, defined as a worsening of COPD respiratory symptoms that resulted in a course of antibiotics and/or oral steroids; or an unscheduled visit to GP, urgent care, Emergency Department or as an inpatient. Data will be validated against medical records using data linkage.	24 weeks post-randomisation
Urge to smoke/cravings	The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).	12 weeks post-randomisation
Urge to smoke/cravings	The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).	24 weeks post-randomisation
Cigarette dependence	Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence	12 weeks post-randomisation
Cigarette dependence	Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence	24 weeks post-randomisation
Health-related quality of life	Measured using the EQ-5D	12 weeks post-randomisation
Health-related quality of life	Measured using the EQ-5D	24 weeks post-randomisation
Serious adverse events		12 weeks post-randomisation
Serious adverse events		24 weeks post-randomisation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence (Script redeemed)	Question asked about whether they redeemed their allocated script	12 weeks post-randomisation
Question about medication compliance (pill count).	Ask about how many of their allocated pills they took	12 weeks post-randomisation
Question about use of other cessation products	Questions will be asked about whether other cessation products were used and if so, what type. E-cigarettes will be considered a possible cessation product.	12 weeks post-randomisation
Questions asked about the use of other cessation products	Questions will be asked about whether other cessation products were used and if so, what type. E-cigarettes will be considered a possible cessation product.	24 weeks post-randomisation

Collaborators and Investigators

• Sponsor: University of Auckland, New Zealand
• Investigators: Principal Investigator: Natalie Walker, PhD, University of Auckland, New Zealand

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Actual): April 13, 2018
• Study Completion (Actual): April 13, 2018

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): September 5, 2016

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No