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