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Chronic Obstructive Pulmonary DiseasePhase 3SPACENCT02888444

Smoking Relapse Prevention Among COPD Ex-smokers

A Phase 3 study testing Varenicline and Behavioural support in people with Chronic Obstructive Pulmonary Disease and Smoking Cessation, run by University of Auckland, New Zealand at 1 site in New Zealand.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Varenicline and Behavioural support
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
1 siteNew Zealand
Study dates
31 Jul 2017to 13 Apr 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

New Zealand1 site

  • National Institute for Health Innovation, University of Auckland

    Auckland

Other trials in New Zealand

About this study

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

Read the 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.

Being tested
Varenicline, Behavioural support, Placebo
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VareniclineDrug

    Also called Champix

    Two 0.5mg tablets taken twice daily

  • Behavioural supportBehavioural

    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.

  • PlaceboDrug

    Two 0.5mg tablets taken twice daily

Study groups in NCT02888444
Study groupRoleWhat they receive
Varenicline plus behavioural supportActive comparator12 weeks extended treatment with varenicline, plus relapse prevention-orientated behavioural support
Receives: Drug: Varenicline; Behavioral: Behavioural support
Placebo plus behavioural supportPlacebo comparator12 weeks extended treatment with placebo, plus relapse prevention-orientated behavioural support
Receives: Behavioral: Behavioural support; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Continuous abstinence

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

    Measured: 12 weeks post-randomisation

Secondary outcomes (19)

  1. Continuous abstinence

    Biochemically validated continuous (lapse-free) abstinence

    Measured: 24 weeks post-randomisation

  2. 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.

    Measured: 12 weeks post-randomisation

  3. 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.

    Measured: 24 weeks post-randomisation

  4. Time to lapse

    Time to first lapse, defined as time to first cigarette smoked (even a puff)

    Measured: 12 weeks post-randomisation

  5. Time to lapse

    Time to first lapse, defined as time to first cigarette smoked (even a puff)

    Measured: 24 weeks post-randomisation

  6. Time to relapse

    Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.

    Measured: 12 weeks post-randomisation

  7. Time to relapse

    Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.

    Measured: 24 weeks post-randomisation

  8. Cigarettes per day

    Cigarettes smoked per day, if returned to smoking

    Measured: 12 weeks post-randomisation

  9. Cigarettes per day

    Cigarettes smoked per day, if returned to smoking

    Measured: 24 weeks post-randomisation

  10. 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.

    Measured: 12 weeks post-randomisation

  11. 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.

    Measured: 24 weeks post-randomisation

  12. Urge to smoke/cravings

    The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).

    Measured: 12 weeks post-randomisation

  13. Urge to smoke/cravings

    The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).

    Measured: 24 weeks post-randomisation

  14. Cigarette dependence

    Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence

    Measured: 12 weeks post-randomisation

  15. Cigarette dependence

    Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence

    Measured: 24 weeks post-randomisation

  16. Health-related quality of life

    Measured using the EQ-5D

    Measured: 12 weeks post-randomisation

  17. Health-related quality of life

    Measured using the EQ-5D

    Measured: 24 weeks post-randomisation

  18. Serious adverse events

    Measured: 12 weeks post-randomisation

  19. Serious adverse events

    Measured: 24 weeks post-randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2016 (estimated)
  2. Study start31 Jul 2017
  3. Primary completion13 Apr 2018
  4. Study completion13 Apr 2018

Why it stopped: Poor recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02888444
Sponsor's protocol ID
113
Acronym
SPACE
Status last verified
May 2019
First submitted
30 Aug 2016
Last updated
15 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Varenicline and Behavioural support in people with Chronic Obstructive Pulmonary Disease and Smoking Cessation, run by University of Auckland, New Zealand at 1 site in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Continuous abstinence (time frame: 12 weeks post-randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02888444.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.

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