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临床试验/NCT02922387
NCT02922387已完成4 期

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

General Hospital of Kavala0 个研究点目标入组 101 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
101
主要终点
Smoking Cessation Rate at week 52

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Varenicline + Behavioral support

Experimental

varenicline and behavioral support

干预措施: Varenicline (Drug)

Varenicline + Behavioral support

Experimental

varenicline and behavioral support

干预措施: Behavioral support (Behavioral)

Behavioral support

Active Comparator

behavioral support

干预措施: Behavioral support (Behavioral)

结局指标

主要结局

Smoking Cessation Rate at week 52

时间窗: 12 months follow up

次要结局

  • Quality of life changes following smoking cessation(12 months follow up)

研究者

发起方
General Hospital of Kavala
申办方类型
Other
责任方
Principal Investigator
主要研究者

ALEXIOS POLITIS

Principal Investigator

General Hospital of Kavala

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