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
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
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
NCT ID
NCT02922387
First Posted
September 27, 2016
Last Updated
September 30, 2016
Sponsor
General Hospital of Kavala
Collaborators
University of Thessaly
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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