Smoking Cessation Intervention in Respiratory Inpatients

Sponsor

General Hospital of Kavala (Other)

Overall Status

Completed

CT.gov ID

NCT02922387

Collaborator

University of Thessaly (Other)

101

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

Prospective, open-label, parallel-group, 52-week trial comparing varenicline in combination with behavioral support with one session of behavioral support alone.

Eligible patients were smokers hospitalized due to a) acute exacerbation of chronic obstructive pulmonary disease (COPD), or b) bronchial asthma attack, or c) community-acquired pneumonia (CAP).

The primary outcome was the success rate (%) at week 52. Secondary outcomes were quality of life (QoL) alterations on the domains of the 36-Item Short Form Health Survey (SF36) and investigation of possible predictors for smoking abstinence.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive Asthma Community Acquired Pneumonia	Drug: Varenicline Behavioral: Behavioral support	Phase 4

Detailed Description

Patients screened for eligibility were all the smokers who were hospitalized in the First Pulmonology Clinic of Kavala General Hospital from May 2012 to May 2014.

Patients had an initial private consultation session and motivational interview while still in the hospital. Following this interview, patients chose the smoking cessation intervention they preferred: either the standard regimen for varenicline and behavioral support or behavioral support without pharmacotherapy.

All patients quit smoking while still hospitalized.Follow-up phone calls with a minimum duration of 10 minutes were scheduled in weeks 1, 2, 4, and months 3,6 and 9 following smoking cessation.

Patients in both groups were asked to return to hospital in month 12 (week 52) for a final assessment. At this last visit, the SF36 was again completed and exhaled CO was (re) measured.

Study Design

Study Type:

Interventional

Actual Enrollment :

101 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Varenicline and Advanced Behavioral Support on Smoking Cessation and Quality of Life in Inpatients With Acute Exacerbation of COPD, Bronchial Asthma Attack, or Community-acquired Pneumonia: a Prospective Open-label 52-week Follow-up Trial

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Varenicline + Behavioral support varenicline and behavioral support	Drug: Varenicline Varenicline was given for 12 weeks to all patients in group A. The initial dose was 0.5 mg/day for days 1-3, and was then up-titrated to 0.5mg on days 4-7, and finally to 1 mg twice daily from day 8 until the end of treatment Other Names: Chantix Behavioral: Behavioral support An initial private consultation session and motivational interview while still in the hospital that lasted for at least 60 minutes. Follow-up phone calls with a minimum duration of 10 minutes were scheduled in weeks 1, 2, 4, and months 3,6 and 9 following smoking cessation. Other Names: motivational interview consultation session
Active Comparator: Behavioral support behavioral support	Behavioral: Behavioral support An initial private consultation session and motivational interview while still in the hospital that lasted for at least 60 minutes. Follow-up phone calls with a minimum duration of 10 minutes were scheduled in weeks 1, 2, 4, and months 3,6 and 9 following smoking cessation. Other Names: motivational interview consultation session

Arm

Intervention/Treatment

Experimental: Varenicline + Behavioral support

varenicline and behavioral support

Drug: Varenicline

Varenicline was given for 12 weeks to all patients in group A. The initial dose was 0.5 mg/day for days 1-3, and was then up-titrated to 0.5mg on days 4-7, and finally to 1 mg twice daily from day 8 until the end of treatment

Other Names:

Chantix

Behavioral: Behavioral support

An initial private consultation session and motivational interview while still in the hospital that lasted for at least 60 minutes. Follow-up phone calls with a minimum duration of 10 minutes were scheduled in weeks 1, 2, 4, and months 3,6 and 9 following smoking cessation.

Other Names:

motivational interview

consultation session

Active Comparator: Behavioral support

behavioral support

Behavioral: Behavioral support

Other Names:

motivational interview

consultation session

Outcome Measures

Primary Outcome Measures

Smoking Cessation Rate at week 52 [12 months follow up]

Secondary Outcome Measures

Quality of life changes following smoking cessation [12 months follow up]
Quality of life (QoL) was assessed, in both groups, with the Short Form SF36 questionnaire at baseline and at the end of the followup period, week 52.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Adult smokers (> 100 cigarettes in their lifetime)
Patients hospitalized due to either a) acute exacerbation of COPD, or b) acute exacerbation of bronchial asthma, or c) community acquired pneumonia.
Patients who agreed to participate and provided written informed consent were recruited.

Exclusion criteria:

Inpatients younger than 18
adult smokers hospitalized for any reason other than acute exacerbation of COPD / bronchial asthma or community acquired pneumonia.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

General Hospital of Kavala
University of Thessaly

Investigators

Study Director: Konstantinos I Gourgoulianis, Prof., Department of Respiratory Medicine, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece