NCT02888444

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_3 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_3 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

July 31, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2018

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

August 30, 2016

Last Update Submit

May 13, 2019

Conditions

Chronic Obstructive Pulmonary DiseaseSmoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Continuous abstinence

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

    12 weeks post-randomisation

Secondary Outcomes (19)

  • Continuous abstinence

    24 weeks post-randomisation

  • 7-day point prevalence abstinence

    12 weeks post-randomisation

  • 7-day point prevalence abstinence

    24 weeks post-randomisation

  • Time to lapse

    12 weeks post-randomisation

  • Time to lapse

    24 weeks post-randomisation

  • +14 more secondary outcomes

Other Outcomes (4)

  • Medication adherence (Script redeemed)

    12 weeks post-randomisation

  • Question about medication compliance (pill count).

    12 weeks post-randomisation

  • Question about use of other cessation products

    12 weeks post-randomisation

  • +1 more other outcomes

Study Arms (2)

Varenicline plus behavioural support

ACTIVE COMPARATOR

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

Drug: VareniclineBehavioral: Behavioural support

Placebo plus behavioural support

PLACEBO COMPARATOR

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

Behavioral: Behavioural supportDrug: Placebo

Interventions

VareniclineDRUG

Two 0.5mg tablets taken twice daily

Also known as: Champix
Varenicline plus behavioural support
Behavioural supportBEHAVIORAL

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 plus behavioural supportVarenicline plus behavioural support
PlaceboDRUG

Two 0.5mg tablets taken twice daily

Placebo plus behavioural support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Health Innovation, University of Auckland

Auckland, New Zealand

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSmoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Natalie Walker, PhD

    University of Auckland, New Zealand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 5, 2016

Study Start

July 31, 2017

Primary Completion

April 13, 2018

Study Completion

April 13, 2018

Last Updated

May 15, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)