Smoking Cessation Intervention in Respiratory Inpatients

NCT02922387 | Completed Phase 4

• 1 other identifier: VTBSQOL-52-CAC
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Community Acquired Pneumonia

Keywords

varenicline; COPD; asthma; pneumonia; smoking cessation

Outcome Measures

Primary Outcomes (1)

• Smoking Cessation Rate at week 52

  12 months follow up

Secondary Outcomes (1)

• Quality of life changes following smoking cessation

  12 months follow up

Study Arms (2)

Varenicline + Behavioral support

EXPERIMENTAL

varenicline and behavioral support

Drug: Varenicline; Behavioral: Behavioral support

Behavioral support

ACTIVE COMPARATOR

behavioral support

Behavioral: Behavioral support

Interventions

Varenicline DRUG

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

Also known as: Chantix

Varenicline + Behavioral support

Behavioral support BEHAVIORAL

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.

Also known as: motivational interview, consultation session

Behavioral support; Varenicline + Behavioral support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inpatients younger than 18
• adult smokers hospitalized for any reason other than acute exacerbation of COPD / bronchial asthma or community acquired pneumonia.

Sponsors & Collaborators

• General Hospital of Kavala: lead
• University of Thessaly: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Community-Acquired Pneumonia; Pneumonia; Smoking Cessation

Interventions

Varenicline; Behavior Therapy; Motivational Interviewing

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Community-Acquired Infections; Infections; Respiratory Tract Infections; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Psychotherapy; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Konstantinos I Gourgoulianis, Prof.

  Department of Respiratory Medicine, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 4, 2016
• Study Start: May 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 4, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share