Smoking Relapse Prevention Among COPD Ex-smokers

Chronic Obstructive Pulmonary Disease Clinical Trial

— SPACE  

Official title:

Smoking Relapse Prevention Among COPD Ex-smokers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02888444
• Other study ID #: 113
• Status: Terminated
• Phase: Phase 3
• Start date: July 31, 2017
• Est. completion date: April 13, 2018

Study information

• Verified date: May 2019
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 13, 2018
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Smoking Cessation

Intervention

Drug:
• Varenicline
Two 0.5mg tablets taken twice daily

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

Locations

Country	Name	City	State
New Zealand	National Institute for Health Innovation, University of Auckland	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
University of Auckland, New Zealand

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medication adherence (Script redeemed)	Question asked about whether they redeemed their allocated script	12 weeks post-randomisation
Other	Question about medication compliance (pill count).	Ask about how many of their allocated pills they took	12 weeks post-randomisation
Other	Question about use of other cessation products	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
Other	Questions asked about the use of other cessation products	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
Primary	Continuous abstinence	Continuous (lapse-free) abstinence biochemically validated using a carbon monoxide reading of <10 ppm.	12 weeks post-randomisation
Secondary	Continuous abstinence	Biochemically validated continuous (lapse-free) abstinence	24 weeks post-randomisation
Secondary	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.	12 weeks post-randomisation
Secondary	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.	24 weeks post-randomisation
Secondary	Time to lapse	Time to first lapse, defined as time to first cigarette smoked (even a puff)	12 weeks post-randomisation
Secondary	Time to lapse	Time to first lapse, defined as time to first cigarette smoked (even a puff)	24 weeks post-randomisation
Secondary	Time to relapse	Time to first relapse, defined as smoking =five cigarettes a day for three consecutive days.	12 weeks post-randomisation
Secondary	Time to relapse	Time to first relapse, defined as smoking =five cigarettes a day for three consecutive days.	24 weeks post-randomisation
Secondary	Cigarettes per day	Cigarettes smoked per day, if returned to smoking	12 weeks post-randomisation
Secondary	Cigarettes per day	Cigarettes smoked per day, if returned to smoking	24 weeks post-randomisation
Secondary	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.	12 weeks post-randomisation
Secondary	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.	24 weeks post-randomisation
Secondary	Urge to smoke/cravings	The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).	12 weeks post-randomisation
Secondary	Urge to smoke/cravings	The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).	24 weeks post-randomisation
Secondary	Cigarette dependence	Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence	12 weeks post-randomisation
Secondary	Cigarette dependence	Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence	24 weeks post-randomisation
Secondary	Health-related quality of life	Measured using the EQ-5D	12 weeks post-randomisation
Secondary	Health-related quality of life	Measured using the EQ-5D	24 weeks post-randomisation
Secondary	Serious adverse events		12 weeks post-randomisation
Secondary	Serious adverse events		24 weeks post-randomisation