FF/UMEC/VI: Qualitative Interviews and Discrete Choice Experiment(s) Evaluating the Perceived Benefits of the Features of FF/UMEC/VI (Single Inhaler Triple Therapy) Treatment in the UK, US and Germany
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 634
- 试验地点
- 1
- 主要终点
- Evaluation of the key relevant attributes of COPD treatment
研究概览
简要总结
Three main classes of inhaled treatment exist for chronic obstructive pulmonary disease (COPD): Beta2-adrenergic agonists (which may be short (SABA) or long (LABA) acting), long-acting muscarinic acetylcholine receptor antagonists (LAMA), and inhaled corticosteroids (ICS). For subjects at higher risk of exacerbation, treatment with all these three classes of medication is recommended. This study aims to explore the potential utility of a device called single inhaler triple combination or fluticasone furoate/ umeclidinium/ vilanterol (FF/UMEC/VI) inhaler containing all three groups of compound. This is a mixed methods study with a qualitative phase and a quantitative Discrete Choice Experiment (DCE) phase and will be conducted in four stages: qualitative concept elicitation, DCE development, DCE piloting and testing, and conduct of the DCE. The study will conducted in the United Kingdom (UK), United States (US) and Germany and approximately 573 subjects with COPD will be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD, self-reported.
- •Age: More than or equal to 40 years.
- •Moderate to severe COPD, indicated by a COPD Assessment Test (CAT) score of greater than or equal to 10 or Modified Medical Research Council (MMRC) score of greater than or equal to
- •Currently prescribed and receiving one of the following treatment types: ICS/LABA; LABA/LAMA; ICS/LABA/LAMA (triple therapy); LAMA.
- •Currently resident in the UK, US or Germany.
- •Adequate written and oral fluency in language of country of residence.
- •Willing and able to understand the study and provide informed consent.
- •Has access to the internet (Cognitive interviews and DCE survey only).
排除标准
- •Has taken part in any other stage of this study.
- •Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD).
- •Any co-morbidity that would inhibit the ability to provide informed consent or allow participation in a telephone of face-to-face interview.
结局指标
主要结局
Evaluation of the key relevant attributes of COPD treatment
时间窗: Up to 368 hours
The key attributes considered to be most important to subjects with COPD when making treatment choices will be assessed using the data from the subject interviews and focus groups.
Evaluation of the preferences, priorities and treatment goals of subjects with COPD for inhaled treatments
时间窗: Up to 368 hours
The probability of choosing one treatment over another will be evaluated using DCE survey questionnaire.
次要结局
- Assessment of the relative appeal of different treatment approaches(Up to 371 hours)
- Estimation of the relative importance of each attribute(Up to 371 hours)