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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02888444
Registration number
NCT02888444
Ethics application status
Date submitted
30/08/2016
Date registered
5/09/2016
Date last updated
15/05/2019
Titles & IDs
Public title
Smoking Relapse Prevention Among COPD Ex-smokers
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Scientific title
Smoking Relapse Prevention Among COPD Ex-smokers
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Secondary ID [1]
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113
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Universal Trial Number (UTN)
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Trial acronym
SPACE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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Smoking Cessation
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Varenicline
Behaviour - Behavioural support
Treatment: Drugs - Placebo
Active Comparator: Varenicline plus behavioural support - 12 weeks extended treatment with varenicline, plus relapse prevention-orientated behavioural support
Placebo Comparator: Placebo plus behavioural support - 12 weeks extended treatment with placebo, plus relapse prevention-orientated behavioural support
Treatment: Drugs: Varenicline
Two 0.5mg tablets taken twice daily
Behaviour: 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.
Treatment: Drugs: Placebo
Two 0.5mg tablets taken twice daily
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Continuous abstinence
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Assessment method [1]
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Continuous (lapse-free) abstinence biochemically validated using a carbon monoxide reading of <10 ppm.
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Timepoint [1]
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12 weeks post-randomisation
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Secondary outcome [1]
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Continuous abstinence
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Assessment method [1]
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Biochemically validated continuous (lapse-free) abstinence
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Timepoint [1]
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24 weeks post-randomisation
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Secondary outcome [2]
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7-day point prevalence abstinence
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Assessment method [2]
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Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff.
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Timepoint [2]
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12 weeks post-randomisation
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Secondary outcome [3]
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7-day point prevalence abstinence
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Assessment method [3]
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Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff.
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Timepoint [3]
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24 weeks post-randomisation
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Secondary outcome [4]
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Time to lapse
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Assessment method [4]
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Time to first lapse, defined as time to first cigarette smoked (even a puff)
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Timepoint [4]
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12 weeks post-randomisation
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Secondary outcome [5]
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Time to lapse
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Assessment method [5]
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Time to first lapse, defined as time to first cigarette smoked (even a puff)
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Timepoint [5]
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24 weeks post-randomisation
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Secondary outcome [6]
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Time to relapse
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Assessment method [6]
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Time to first relapse, defined as smoking =five cigarettes a day for three consecutive days.
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Timepoint [6]
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12 weeks post-randomisation
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Secondary outcome [7]
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Time to relapse
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Assessment method [7]
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Time to first relapse, defined as smoking =five cigarettes a day for three consecutive days.
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Timepoint [7]
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24 weeks post-randomisation
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Secondary outcome [8]
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Cigarettes per day
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Assessment method [8]
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Cigarettes smoked per day, if returned to smoking
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Timepoint [8]
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12 weeks post-randomisation
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Secondary outcome [9]
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Cigarettes per day
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Assessment method [9]
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Cigarettes smoked per day, if returned to smoking
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Timepoint [9]
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24 weeks post-randomisation
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Secondary outcome [10]
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COPD exacerbations requiring hospitalisation
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Assessment method [10]
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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.
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Timepoint [10]
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12 weeks post-randomisation
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Secondary outcome [11]
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COPD exacerbations requiring hospitalisation
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Assessment method [11]
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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.
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Timepoint [11]
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24 weeks post-randomisation
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Secondary outcome [12]
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Urge to smoke/cravings
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Assessment method [12]
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The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).
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Timepoint [12]
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12 weeks post-randomisation
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Secondary outcome [13]
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Urge to smoke/cravings
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Assessment method [13]
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The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).
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Timepoint [13]
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24 weeks post-randomisation
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Secondary outcome [14]
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Cigarette dependence
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Assessment method [14]
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Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence
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Timepoint [14]
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12 weeks post-randomisation
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Secondary outcome [15]
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Cigarette dependence
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Assessment method [15]
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Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence
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Timepoint [15]
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24 weeks post-randomisation
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Secondary outcome [16]
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Health-related quality of life
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Assessment method [16]
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Measured using the EQ-5D
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Timepoint [16]
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12 weeks post-randomisation
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Secondary outcome [17]
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Health-related quality of life
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Assessment method [17]
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Measured using the EQ-5D
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Timepoint [17]
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24 weeks post-randomisation
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Secondary outcome [18]
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Serious adverse events
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Assessment method [18]
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0
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Timepoint [18]
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12 weeks post-randomisation
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Secondary outcome [19]
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Serious adverse events
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Assessment method [19]
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Timepoint [19]
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24 weeks post-randomisation
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/07/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/04/2018
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Sample size
Target
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Accrual to date
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Final
8
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Auckland, New Zealand
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02888444
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Natalie Walker, PhD
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Address
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University of Auckland, New Zealand
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02888444
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