EUCTR2010-024208-81-DK进行中（未招募）不适用
Smoking young asthmatics: Change of inflammation and quitting cessation rate – effect of Champix
Christian Westergaard0 个研究点目标入组 84 人开始时间: 2011年1月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In total, 84 asthmatics will be included, in the age of 18-40 years, with at least 10 packyears, and at present current smokers with 10 cigarettes per day within the last 12 months.
- •All asthmatics should at visit 0 or before have symptoms of asthma or signs of reversible airway disease, i.e. a history of reversible airway disease within the last 12 months, assessed by asthma questionaires, or at least one of the following: 1) a current increase of 12% after ?2-agonist, 2) positive methacholine test, 3) positive mannitol test, 4) positive eucapnic hyperventilation test (EVH) or 5) 20% day-to-day FEV1 variation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Asthmatics who have been treated with inhaled corticosteroids (ICS), systemic corticosteroids, leukotrien-antagonists (LTA), long-lasting ?2-agonists, anticholinergic medicine or varenicline within the last 3 months will be excluded, as well as those with lower respiratory tract infections, including pneumonia, within the last 6 weeks. Patients suffering from other chronic respiratory disease than asthma, such as sarcoidosis and COPD will also be excluded. Pregnant and nursing women will be excluded as well as women planning pregnancy during the study period. Lastly, a history of allergy towards study drugs will lead to exclusion.
- •Patients who during the study period develope lower respiratory infections or due to severe uncontrolled asthma receive treatment with any of the above listed types of medicine will be excluded. Patiens who are diagnosed with other chronic respiratory disease than asthma during the study period will also be excluded as well as patients who during the study period require more asthma medicine than stated in this protocol.
- •Any participant who wishes to to leave the study, for any reason, including unacceptable side-effects, during the study period will be excluded, as well as anyone who wants to withdraw their recorded data from the project after the study period has ended.
- •In case of unacceptable side-effects to varenicline resulting in immediate cessation of treatment with this drug, the participant will continue visits unchanged, but he/she will be excluded from the calculations of tobacco cessation succes-rate. However, varenicline cessation up to 4 weeks after treatment start with varenicline will results in exclusion and replacement of the participant.
- •Cessation of treatment with budesonide will result in exclusion from the rest the study. The person will not be replaced. The data recorded from the participant until the last visit before cessation will be used (last visit will be included).
- •Allergic reactions towards study drugs will result in immediate cessation of the drug, and possible exclusion, as described in the above.
研究者
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