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Smoking Relapse Prevention Among COPD Ex-smokers (SPACE)

Primary Purpose

Chronic Obstructive Pulmonary Disease, Smoking Cessation

Status
Terminated
Phase
Phase 3
Locations
New Zealand
Study Type
Interventional
Intervention
Varenicline
Behavioural support
Placebo
Sponsored by
University of Auckland, New Zealand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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)

Sites / Locations

  • National Institute for Health Innovation, University of Auckland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Varenicline plus behavioural support

Placebo plus behavioural support

Arm Description

12 weeks extended treatment with varenicline, plus relapse prevention-orientated behavioural support

12 weeks extended treatment with placebo, plus relapse prevention-orientated behavioural support

Outcomes

Primary Outcome Measures

Continuous abstinence
Continuous (lapse-free) abstinence biochemically validated using a carbon monoxide reading of <10 ppm.

Secondary Outcome Measures

Continuous abstinence
Biochemically validated continuous (lapse-free) abstinence
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.
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.
Time to lapse
Time to first lapse, defined as time to first cigarette smoked (even a puff)
Time to lapse
Time to first lapse, defined as time to first cigarette smoked (even a puff)
Time to relapse
Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.
Time to relapse
Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.
Cigarettes per day
Cigarettes smoked per day, if returned to smoking
Cigarettes per day
Cigarettes smoked per day, if returned to smoking
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.
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.
Urge to smoke/cravings
The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).
Urge to smoke/cravings
The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).
Cigarette dependence
Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence
Cigarette dependence
Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence
Health-related quality of life
Measured using the EQ-5D
Health-related quality of life
Measured using the EQ-5D
Serious adverse events
Serious adverse events

Full Information

First Posted
August 30, 2016
Last Updated
May 13, 2019
Sponsor
University of Auckland, New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT02888444
Brief Title
Smoking Relapse Prevention Among COPD Ex-smokers
Acronym
SPACE
Official Title
Smoking Relapse Prevention Among COPD Ex-smokers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
April 13, 2018 (Actual)
Study Completion Date
April 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Auckland, New Zealand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Smoking remains the leading cause of Chronic Obstructive Pulmonary Disease (COPD), a leading cause of death and disability in New Zealand. COPD particularly affects indigenous Māori and Pacific people, given their higher rates of smoking. COPD patients tend to have a higher level of nicotine dependence and, as a result, often find quitting harder and are more likely to relapse back to smoking. A clinical trial (N=262) is planned in Auckland, New Zealand to determine whether extended varenicline treatment combined with behavioural support can prevent relapse back to smoking in recent ex-smokers with COPD. Smoking cessation and relapse prevention are the most cost-effective interventions available for COPD patients that smoke, irrespective of their disease stage. The trial has the potential to significantly improve the outcomes of this common and chronic health condition in New Zealand.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Smoking Cessation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Varenicline plus behavioural support
Arm Type
Active Comparator
Arm Description
12 weeks extended treatment with varenicline, plus relapse prevention-orientated behavioural support
Arm Title
Placebo plus behavioural support
Arm Type
Placebo Comparator
Arm Description
12 weeks extended treatment with placebo, plus relapse prevention-orientated behavioural support
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Champix
Intervention Description
Two 0.5mg tablets taken twice daily
Intervention Type
Behavioral
Intervention Name(s)
Behavioural support
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two 0.5mg tablets taken twice daily
Primary Outcome Measure Information:
Title
Continuous abstinence
Description
Continuous (lapse-free) abstinence biochemically validated using a carbon monoxide reading of <10 ppm.
Time Frame
12 weeks post-randomisation
Secondary Outcome Measure Information:
Title
Continuous abstinence
Description
Biochemically validated continuous (lapse-free) abstinence
Time Frame
24 weeks post-randomisation
Title
7-day point prevalence abstinence
Description
Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff.
Time Frame
12 weeks post-randomisation
Title
7-day point prevalence abstinence
Description
Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff.
Time Frame
24 weeks post-randomisation
Title
Time to lapse
Description
Time to first lapse, defined as time to first cigarette smoked (even a puff)
Time Frame
12 weeks post-randomisation
Title
Time to lapse
Description
Time to first lapse, defined as time to first cigarette smoked (even a puff)
Time Frame
24 weeks post-randomisation
Title
Time to relapse
Description
Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.
Time Frame
12 weeks post-randomisation
Title
Time to relapse
Description
Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.
Time Frame
24 weeks post-randomisation
Title
Cigarettes per day
Description
Cigarettes smoked per day, if returned to smoking
Time Frame
12 weeks post-randomisation
Title
Cigarettes per day
Description
Cigarettes smoked per day, if returned to smoking
Time Frame
24 weeks post-randomisation
Title
COPD exacerbations requiring hospitalisation
Description
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.
Time Frame
12 weeks post-randomisation
Title
COPD exacerbations requiring hospitalisation
Description
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.
Time Frame
24 weeks post-randomisation
Title
Urge to smoke/cravings
Description
The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).
Time Frame
12 weeks post-randomisation
Title
Urge to smoke/cravings
Description
The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).
Time Frame
24 weeks post-randomisation
Title
Cigarette dependence
Description
Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence
Time Frame
12 weeks post-randomisation
Title
Cigarette dependence
Description
Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence
Time Frame
24 weeks post-randomisation
Title
Health-related quality of life
Description
Measured using the EQ-5D
Time Frame
12 weeks post-randomisation
Title
Health-related quality of life
Description
Measured using the EQ-5D
Time Frame
24 weeks post-randomisation
Title
Serious adverse events
Time Frame
12 weeks post-randomisation
Title
Serious adverse events
Time Frame
24 weeks post-randomisation
Other Pre-specified Outcome Measures:
Title
Medication adherence (Script redeemed)
Description
Question asked about whether they redeemed their allocated script
Time Frame
12 weeks post-randomisation
Title
Question about medication compliance (pill count).
Description
Ask about how many of their allocated pills they took
Time Frame
12 weeks post-randomisation
Title
Question about use of other cessation products
Description
Questions will be asked about whether other cessation products were used and if so, what type. E-cigarettes will be considered a possible cessation product.
Time Frame
12 weeks post-randomisation
Title
Questions asked about the use of other cessation products
Description
Questions will be asked about whether other cessation products were used and if so, what type. E-cigarettes will be considered a possible cessation product.
Time Frame
24 weeks post-randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Walker, PhD
Organizational Affiliation
University of Auckland, New Zealand
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute for Health Innovation, University of Auckland
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Smoking Relapse Prevention Among COPD Ex-smokers

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