Smoking Cessation Intervention in Respiratory Inpatients

Phase 4

Completed

• Conditions: Community Acquired Pneumonia; Pulmonary Disease, Chronic Obstructive; Asthma
• Interventions: Drug: Varenicline; Behavioral: Behavioral support

• Registration Number: NCT02922387
• Lead Sponsor: General Hospital of Kavala

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.

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 Timeline

• Study Start: 2012-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-09
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-30
• Last Update Submitted: 2016-09-30
• Study First Posted: 2016-10-04
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline + Behavioral support	Varenicline	varenicline and behavioral support
Varenicline + Behavioral support	Behavioral support	varenicline and behavioral support
Behavioral support	Behavioral support	behavioral support

Primary Outcome Measures

Name	Time	Method
Smoking Cessation Rate at week 52	12 months follow up

Secondary Outcome Measures

Name	Time	Method
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.