Smoking Cessation Intervention in Respiratory Inpatients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pulmonary Disease, Chronic Obstructive, Asthma, Community Acquired Pneumonia

Intervention / Treatment
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* Drug: Varenicline
* Behavioral: Behavioral support


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline + Behavioral support<br>varenicline and behavioral support | Drug: Varenicline<br>* 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<br>* Other names: Chantix;Behavioral: Behavioral support<br>* 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.<br>* Other names: consultation session;|
| Active Comparator: Behavioral support<br>behavioral support | Behavioral: Behavioral support<br>* 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.<br>* Other names: consultation session;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Cessation Rate at week 52 |  | 12 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life changes following smoking cessation | 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. | 12 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varenicline, COPD, asthma, pneumonia, smoking cessation