Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02888444
Registration number
NCT02888444
Ethics application status
Date submitted
30/08/2016
Date registered
5/09/2016
Titles & IDs
Public title
Smoking Relapse Prevention Among COPD Ex-smokers
Query!
Scientific title
Smoking Relapse Prevention Among COPD Ex-smokers
Query!
Secondary ID [1]
0
0
113
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SPACE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
0
0
Query!
Smoking Cessation
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Chronic obstructive pulmonary disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Varenicline
BEHAVIORAL - 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
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.
Treatment: Drugs: Placebo
Two 0.5mg tablets taken twice daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
BEHAVIORAL
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Continuous abstinence
Query!
Assessment method [1]
0
0
Continuous (lapse-free) abstinence biochemically validated using a carbon monoxide reading of \<10 ppm.
Query!
Timepoint [1]
0
0
12 weeks post-randomisation
Query!
Secondary outcome [1]
0
0
Continuous abstinence
Query!
Assessment method [1]
0
0
Biochemically validated continuous (lapse-free) abstinence
Query!
Timepoint [1]
0
0
24 weeks post-randomisation
Query!
Secondary outcome [2]
0
0
7-day point prevalence abstinence
Query!
Assessment method [2]
0
0
Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff.
Query!
Timepoint [2]
0
0
12 weeks post-randomisation
Query!
Secondary outcome [3]
0
0
7-day point prevalence abstinence
Query!
Assessment method [3]
0
0
Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff.
Query!
Timepoint [3]
0
0
24 weeks post-randomisation
Query!
Secondary outcome [4]
0
0
Time to lapse
Query!
Assessment method [4]
0
0
Time to first lapse, defined as time to first cigarette smoked (even a puff)
Query!
Timepoint [4]
0
0
12 weeks post-randomisation
Query!
Secondary outcome [5]
0
0
Time to lapse
Query!
Assessment method [5]
0
0
Time to first lapse, defined as time to first cigarette smoked (even a puff)
Query!
Timepoint [5]
0
0
24 weeks post-randomisation
Query!
Secondary outcome [6]
0
0
Time to relapse
Query!
Assessment method [6]
0
0
Time to first relapse, defined as smoking =five cigarettes a day for three consecutive days.
Query!
Timepoint [6]
0
0
12 weeks post-randomisation
Query!
Secondary outcome [7]
0
0
Time to relapse
Query!
Assessment method [7]
0
0
Time to first relapse, defined as smoking =five cigarettes a day for three consecutive days.
Query!
Timepoint [7]
0
0
24 weeks post-randomisation
Query!
Secondary outcome [8]
0
0
Cigarettes per day
Query!
Assessment method [8]
0
0
Cigarettes smoked per day, if returned to smoking
Query!
Timepoint [8]
0
0
12 weeks post-randomisation
Query!
Secondary outcome [9]
0
0
Cigarettes per day
Query!
Assessment method [9]
0
0
Cigarettes smoked per day, if returned to smoking
Query!
Timepoint [9]
0
0
24 weeks post-randomisation
Query!
Secondary outcome [10]
0
0
COPD exacerbations requiring hospitalisation
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
12 weeks post-randomisation
Query!
Secondary outcome [11]
0
0
COPD exacerbations requiring hospitalisation
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
24 weeks post-randomisation
Query!
Secondary outcome [12]
0
0
Urge to smoke/cravings
Query!
Assessment method [12]
0
0
The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).
Query!
Timepoint [12]
0
0
12 weeks post-randomisation
Query!
Secondary outcome [13]
0
0
Urge to smoke/cravings
Query!
Assessment method [13]
0
0
The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).
Query!
Timepoint [13]
0
0
24 weeks post-randomisation
Query!
Secondary outcome [14]
0
0
Cigarette dependence
Query!
Assessment method [14]
0
0
Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence
Query!
Timepoint [14]
0
0
12 weeks post-randomisation
Query!
Secondary outcome [15]
0
0
Cigarette dependence
Query!
Assessment method [15]
0
0
Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence
Query!
Timepoint [15]
0
0
24 weeks post-randomisation
Query!
Secondary outcome [16]
0
0
Health-related quality of life
Query!
Assessment method [16]
0
0
Measured using the EQ-5D
Query!
Timepoint [16]
0
0
12 weeks post-randomisation
Query!
Secondary outcome [17]
0
0
Health-related quality of life
Query!
Assessment method [17]
0
0
Measured using the EQ-5D
Query!
Timepoint [17]
0
0
24 weeks post-randomisation
Query!
Secondary outcome [18]
0
0
Serious adverse events
Query!
Assessment method [18]
0
0
Query!
Timepoint [18]
0
0
12 weeks post-randomisation
Query!
Secondary outcome [19]
0
0
Serious adverse events
Query!
Assessment method [19]
0
0
Query!
Timepoint [19]
0
0
24 weeks post-randomisation
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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)
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
31/07/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
13/04/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
8
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
New Zealand
Query!
State/province [1]
0
0
Auckland
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Auckland, New Zealand
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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
Query!
Trial website
https://clinicaltrials.gov/study/NCT02888444
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Natalie Walker, PhD
Query!
Address
0
0
University of Auckland, New Zealand
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02888444