Triple Therapy Convenience by the Use of One or Multiple Inhalers and Digital Support in Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Adherence to ICS therapy
研究概览
简要总结
TRICOLON is an investigator initiated, prospective, interventional, open-label, randomized, real-world, multi-centre, 3-arms study in the Netherlands. The primary objective is to investigate in COPD patients if single-inhaler triple therapy (SITT) is superior to multi-inhaler triple therapy (MITT) in terms of adherence to inhaled corticosteroids (ICS) therapy and to investigate if SITT with e-health support is superior to MITT and SITT without e-health support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Clinical diagnosis of COPD for at least 1 year before the screening visit
- •Aged 40 years and older
- •An indication for triple therapy according to the treating physician (following the GOLD guideline 2021(2)). Could be step-up from dual therapy or currently receiving triple therapy (both MITT and SITT).
- •Owner of mobile device compatible with e-device app with access to internet (Android or iOS)
- •Willing to provide written informed consent
- •Current or ex-smoker
排除标准
- •Inability to comply with study procedures or with study treatment
- •Insufficiently skilled in the Dutch language to be able to read and understand the app. Help by third party (family members) is allowed
- •Asthma as the predominant disease according to the investigator's opinion, a past history of asthma is allowed
- •Use of e-health application for COPD in the past six months
- •Patients with any other therapy that could interfere with the study drugs (according to the investigator's opinion)
- •Use of nebulized bronchodilators, for example via pari boy
- •Pregnant or lactating women and all women physiologically capable of becoming pregnant unless they have highly effective contraceptive
- •Patients mentally or legally incapacitated, or patients accommodated in an establishment as a result of an official or judicial order
- •Patients without the capability to complete the questionnaires
研究组 & 干预措施
Control group
multi-inhaler triple therapy (Qvar and Bevespi)
干预措施: multi-inhaler triple therapy (Qvar + Bevespi) (Drug)
Intervention group 1
single-inhaler triple therapy (Trimbow)
干预措施: single-inhaler triple therapy (Trimbow) (Drug)
Intervention group 2
single-inhaler triple therapy (Trimbow) + e-health applications
干预措施: single-inhaler triple therapy (Trimbow) (Drug)
结局指标
主要结局
Adherence to ICS therapy
时间窗: 12 months
average adherence to ICS therapy (expressed as a percentage, measured as the number of actuations registered by the e-device divided by the total number of prescribed doses) over 12 months of treatment
次要结局
- VAS score(12 months)
- HLS-EU-Q16(12 months)
- SABA use(12 months)
- EQ-5D-5L(12 months)
- Number exacerbations(12 months)
- TAI questionnaire score(12 months)
- CCQ questionnaire(12 months)
- WPAI(12 months)
- PIH-NL(12 months)