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Smoking Relapse Prevention Among COPD Ex-smokers (SPACE)

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ClinicalTrials.gov Identifier: NCT02888444
Recruitment Status : Recruiting
First Posted : September 5, 2016
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Natalie Walker, University of Auckland, New Zealand

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Smoking Cessation Drug: Varenicline Behavioral: Behavioural support Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Smoking Relapse Prevention Among COPD Ex-smokers
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Active Comparator: Varenicline plus behavioural support
12 weeks extended treatment with varenicline, plus relapse prevention-orientated behavioural support
Drug: Varenicline
Two 0.5mg tablets taken twice daily
Other Name: Champix

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.

Placebo Comparator: Placebo plus behavioural support
12 weeks extended treatment with placebo, plus relapse prevention-orientated behavioural support
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.

Drug: Placebo
Two 0.5mg tablets taken twice daily




Primary Outcome Measures :
  1. Continuous abstinence [ Time Frame: 12 weeks post-randomisation ]
    Continuous (lapse-free) abstinence biochemically validated using a carbon monoxide reading of <10 ppm.


Secondary Outcome Measures :
  1. Continuous abstinence [ Time Frame: 24 weeks post-randomisation ]
    Biochemically validated continuous (lapse-free) abstinence

  2. 7-day point prevalence abstinence [ Time Frame: 12 weeks post-randomisation ]
    Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff.

  3. 7-day point prevalence abstinence [ Time Frame: 24 weeks post-randomisation ]
    Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff.

  4. Time to lapse [ Time Frame: 12 weeks post-randomisation ]
    Time to first lapse, defined as time to first cigarette smoked (even a puff)

  5. Time to lapse [ Time Frame: 24 weeks post-randomisation ]
    Time to first lapse, defined as time to first cigarette smoked (even a puff)

  6. Time to relapse [ Time Frame: 12 weeks post-randomisation ]
    Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.

  7. Time to relapse [ Time Frame: 24 weeks post-randomisation ]
    Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.

  8. Cigarettes per day [ Time Frame: 12 weeks post-randomisation ]
    Cigarettes smoked per day, if returned to smoking

  9. Cigarettes per day [ Time Frame: 24 weeks post-randomisation ]
    Cigarettes smoked per day, if returned to smoking

  10. COPD exacerbations requiring hospitalisation [ Time Frame: 12 weeks post-randomisation ]
    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.

  11. COPD exacerbations requiring hospitalisation [ Time Frame: 24 weeks post-randomisation ]
    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.

  12. Urge to smoke/cravings [ Time Frame: 12 weeks post-randomisation ]
    The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).

  13. Urge to smoke/cravings [ Time Frame: 24 weeks post-randomisation ]
    The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).

  14. Cigarette dependence [ Time Frame: 12 weeks post-randomisation ]
    Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence

  15. Cigarette dependence [ Time Frame: 24 weeks post-randomisation ]
    Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence

  16. Health-related quality of life [ Time Frame: 12 weeks post-randomisation ]
    Measured using the EQ-5D

  17. Health-related quality of life [ Time Frame: 24 weeks post-randomisation ]
    Measured using the EQ-5D

  18. Serious adverse events [ Time Frame: 12 weeks post-randomisation ]
  19. Serious adverse events [ Time Frame: 24 weeks post-randomisation ]

Other Outcome Measures:
  1. Medication adherence (Script redeemed) [ Time Frame: 12 weeks post-randomisation ]
    Question asked about whether they redeemed their allocated script

  2. Question about medication compliance (pill count). [ Time Frame: 12 weeks post-randomisation ]
    Ask about how many of their allocated pills they took

  3. Question about use of other cessation products [ Time Frame: 12 weeks post-randomisation ]
    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.

  4. Questions asked about the use of other cessation products [ Time Frame: 24 weeks post-randomisation ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888444


Contacts
Contact: Natalie Walker, PhD 64 9 923 9884 n.walker@auckland.ac.nz
Contact: Chris Bullen, MBChB, PhD 64 9 373 7599 ext 84730 c.bullen@auckland.ac.nz

Locations
New Zealand
National Institute for Health Innovation, University of Auckland Recruiting
Auckland, New Zealand
Contact: Natalie Walker, PhD    64 9 923 9884    n.walker@auckland.ac.nz   
Sponsors and Collaborators
University of Auckland, New Zealand
Investigators
Principal Investigator: Natalie Walker, PhD University of Auckland, New Zealand

Responsible Party: Natalie Walker, Associate Professor, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT02888444     History of Changes
Other Study ID Numbers: 113
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs