Smoking Cessation Intervention in Respiratory Inpatients

General Hospital of Kavala

Status and phase: Completed; Phase 4

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

Treatments: Drug: Varenicline; Behavioral: Behavioral support

Study type: Interventional

Funder types: Other

Identifiers

NCT02922387

VTBSQOL-52-CAC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Varenicline + Behavioral support

Experimental group

Description:

varenicline and behavioral support

Treatment:

Behavioral: Behavioral support

Drug: Varenicline

Behavioral support

Active Comparator group

Description:

behavioral support

Treatment:

Behavioral: Behavioral support