Smoking Cessation Intervention in Respiratory Inpatients

September 30, 2016 updated by: ALEXIOS POLITIS, General Hospital of Kavala

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Smoking Cessation Rate at week 52
Time Frame: 12 months follow up
12 months follow up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Kavala

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTBSQOL-52-CAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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