Smoking Relapse Prevention Among COPD Ex-smokers (SPACE)

May 13, 2019 updated by: Natalie Walker, University of Auckland, New Zealand
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • National Institute for Health Innovation, University of Auckland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Continuous abstinence
Time Frame: 12 weeks post-randomisation
Continuous (lapse-free) abstinence biochemically validated using a carbon monoxide reading of <10 ppm.
12 weeks post-randomisation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Continuous abstinence
Time Frame: 24 weeks post-randomisation
Biochemically validated continuous (lapse-free) abstinence
24 weeks post-randomisation
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.
12 weeks post-randomisation
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.
24 weeks post-randomisation
Time to lapse
Time Frame: 12 weeks post-randomisation
Time to first lapse, defined as time to first cigarette smoked (even a puff)
12 weeks post-randomisation
Time to lapse
Time Frame: 24 weeks post-randomisation
Time to first lapse, defined as time to first cigarette smoked (even a puff)
24 weeks post-randomisation
Time to relapse
Time Frame: 12 weeks post-randomisation
Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.
12 weeks post-randomisation
Time to relapse
Time Frame: 24 weeks post-randomisation
Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.
24 weeks post-randomisation
Cigarettes per day
Time Frame: 12 weeks post-randomisation
Cigarettes smoked per day, if returned to smoking
12 weeks post-randomisation
Cigarettes per day
Time Frame: 24 weeks post-randomisation
Cigarettes smoked per day, if returned to smoking
24 weeks post-randomisation
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.
12 weeks post-randomisation
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.
24 weeks post-randomisation
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).
12 weeks post-randomisation
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).
24 weeks post-randomisation
Cigarette dependence
Time Frame: 12 weeks post-randomisation
Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence
12 weeks post-randomisation
Cigarette dependence
Time Frame: 24 weeks post-randomisation
Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence
24 weeks post-randomisation
Health-related quality of life
Time Frame: 12 weeks post-randomisation
Measured using the EQ-5D
12 weeks post-randomisation
Health-related quality of life
Time Frame: 24 weeks post-randomisation
Measured using the EQ-5D
24 weeks post-randomisation
Serious adverse events
Time Frame: 12 weeks post-randomisation
12 weeks post-randomisation
Serious adverse events
Time Frame: 24 weeks post-randomisation
24 weeks post-randomisation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medication adherence (Script redeemed)
Time Frame: 12 weeks post-randomisation
Question asked about whether they redeemed their allocated script
12 weeks post-randomisation
Question about medication compliance (pill count).
Time Frame: 12 weeks post-randomisation
Ask about how many of their allocated pills they took
12 weeks post-randomisation
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.
12 weeks post-randomisation
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.
24 weeks post-randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Auckland, New Zealand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Natalie Walker, PhD, University of Auckland, New Zealand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 13, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 113 (Shenzhen Universisty general hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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