Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

Outcomes
Primary outcome [1] 0 0
Continuous abstinence
Timepoint [1] 0 0
12 weeks post-randomisation
Secondary outcome [1] 0 0
Continuous abstinence
Timepoint [1] 0 0
24 weeks post-randomisation
Secondary outcome [2] 0 0
7-day point prevalence abstinence
Timepoint [2] 0 0
12 weeks post-randomisation
Secondary outcome [3] 0 0
7-day point prevalence abstinence
Timepoint [3] 0 0
24 weeks post-randomisation
Secondary outcome [4] 0 0
Time to lapse
Timepoint [4] 0 0
12 weeks post-randomisation
Secondary outcome [5] 0 0
Time to lapse
Timepoint [5] 0 0
24 weeks post-randomisation
Secondary outcome [6] 0 0
Time to relapse
Timepoint [6] 0 0
12 weeks post-randomisation
Secondary outcome [7] 0 0
Time to relapse
Timepoint [7] 0 0
24 weeks post-randomisation
Secondary outcome [8] 0 0
Cigarettes per day
Timepoint [8] 0 0
12 weeks post-randomisation
Secondary outcome [9] 0 0
Cigarettes per day
Timepoint [9] 0 0
24 weeks post-randomisation
Secondary outcome [10] 0 0
COPD exacerbations requiring hospitalisation
Timepoint [10] 0 0
12 weeks post-randomisation
Secondary outcome [11] 0 0
COPD exacerbations requiring hospitalisation
Timepoint [11] 0 0
24 weeks post-randomisation
Secondary outcome [12] 0 0
Urge to smoke/cravings
Timepoint [12] 0 0
12 weeks post-randomisation
Secondary outcome [13] 0 0
Urge to smoke/cravings
Timepoint [13] 0 0
24 weeks post-randomisation
Secondary outcome [14] 0 0
Cigarette dependence
Timepoint [14] 0 0
12 weeks post-randomisation
Secondary outcome [15] 0 0
Cigarette dependence
Timepoint [15] 0 0
24 weeks post-randomisation
Secondary outcome [16] 0 0
Health-related quality of life
Timepoint [16] 0 0
12 weeks post-randomisation
Secondary outcome [17] 0 0
Health-related quality of life
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/04/2018
Sample size
Target
Accrual to date
Final
8
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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