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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