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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Smoking Relapse Prevention Among COPD Ex-smokers
Secondary ID [1] 0 0
113
Universal Trial Number (UTN)
Trial acronym
SPACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Smoking Cessation 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Continuous abstinence - Continuous (lapse-free) abstinence biochemically validated using a carbon monoxide reading of <10 ppm.
Timepoint [1] 0 0
12 weeks post-randomisation
Secondary outcome [1] 0 0
Continuous abstinence - Biochemically validated continuous (lapse-free) abstinence
Timepoint [1] 0 0
24 weeks post-randomisation
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
12 weeks post-randomisation
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
24 weeks post-randomisation
Secondary outcome [4] 0 0
Time to lapse - Time to first lapse, defined as time to first cigarette smoked (even a puff)
Timepoint [4] 0 0
12 weeks post-randomisation
Secondary outcome [5] 0 0
Time to lapse - Time to first lapse, defined as time to first cigarette smoked (even a puff)
Timepoint [5] 0 0
24 weeks post-randomisation
Secondary outcome [6] 0 0
Time to relapse - Time to first relapse, defined as smoking =five cigarettes a day for three consecutive days.
Timepoint [6] 0 0
12 weeks post-randomisation
Secondary outcome [7] 0 0
Time to relapse - Time to first relapse, defined as smoking =five cigarettes a day for three consecutive days.
Timepoint [7] 0 0
24 weeks post-randomisation
Secondary outcome [8] 0 0
Cigarettes per day - Cigarettes smoked per day, if returned to smoking
Timepoint [8] 0 0
12 weeks post-randomisation
Secondary outcome [9] 0 0
Cigarettes per day - Cigarettes smoked per day, if returned to smoking
Timepoint [9] 0 0
24 weeks post-randomisation
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
12 weeks post-randomisation
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
24 weeks post-randomisation
Secondary outcome [12] 0 0
Urge to smoke/cravings - The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).
Timepoint [12] 0 0
12 weeks post-randomisation
Secondary outcome [13] 0 0
Urge to smoke/cravings - The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).
Timepoint [13] 0 0
24 weeks post-randomisation
Secondary outcome [14] 0 0
Cigarette dependence - Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence
Timepoint [14] 0 0
12 weeks post-randomisation
Secondary outcome [15] 0 0
Cigarette dependence - Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence
Timepoint [15] 0 0
24 weeks post-randomisation
Secondary outcome [16] 0 0
Health-related quality of life - Measured using the EQ-5D
Timepoint [16] 0 0
12 weeks post-randomisation
Secondary outcome [17] 0 0
Health-related quality of life - Measured using the EQ-5D
Timepoint [17] 0 0
24 weeks post-randomisation
Secondary outcome [18] 0 0
Serious adverse events
Timepoint [18] 0 0
12 weeks post-randomisation
Secondary outcome [19] 0 0
Serious adverse events
Timepoint [19] 0 0
24 weeks post-randomisation

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT02888444
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Natalie Walker, PhD
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02888444