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Smoking Cessation Intervention in Respiratory Inpatients

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Asthma, Community Acquired Pneumonia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Varenicline
Behavioral support
Sponsored by
General Hospital of Kavala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring varenicline, COPD, asthma, pneumonia, smoking cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Varenicline + Behavioral support

    Behavioral support

    Arm Description

    varenicline and behavioral support

    behavioral support

    Outcomes

    Primary Outcome Measures

    Smoking Cessation Rate at week 52

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 27, 2016
    Last Updated
    September 30, 2016
    Sponsor
    General Hospital of Kavala
    Collaborators
    University of Thessaly
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02922387
    Brief Title
    Smoking Cessation Intervention in Respiratory Inpatients
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    General Hospital of Kavala
    Collaborators
    University of Thessaly

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Disease, Chronic Obstructive, Asthma, Community Acquired Pneumonia
    Keywords
    varenicline, COPD, asthma, pneumonia, smoking cessation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    101 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Varenicline + Behavioral support
    Arm Type
    Experimental
    Arm Description
    varenicline and behavioral support
    Arm Title
    Behavioral support
    Arm Type
    Active Comparator
    Arm Description
    behavioral support
    Intervention Type
    Drug
    Intervention Name(s)
    Varenicline
    Other Intervention Name(s)
    Chantix
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Behavioral support
    Other Intervention Name(s)
    motivational interview, consultation session
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Smoking Cessation Rate at week 52
    Time Frame
    12 months follow up
    Secondary Outcome Measure Information:
    Title
    Quality of life changes following smoking cessation
    Description
    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.
    Time Frame
    12 months follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Konstantinos I Gourgoulianis, Prof.
    Organizational Affiliation
    Department of Respiratory Medicine, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Smoking Cessation Intervention in Respiratory Inpatients

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