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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02922387
Other study ID # VTBSQOL-52-CAC
Secondary ID
Status Completed
Phase Phase 4
First received September 27, 2016
Last updated September 30, 2016
Start date May 2012
Est. completion date May 2015

Study information

Verified date September 2016
Source General Hospital of Kavala
Contact n/a
Is FDA regulated No
Health authority Greece: Ministry of Health and WelfareGreece: National Organization of Medicines
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
General Hospital of Kavala University of Thessaly

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking Cessation Rate at week 52 12 months follow up No
Secondary 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. 12 months follow up No
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