BETRI-Prospective: Asthma Control in Single Inhaler ICS/LABA/LAMA (87/5/9 pMDI [BDP/FF/GB - 100/6/12.5 μg]) vs Single Inhaler ICS/LABA (200/6 pMDI [BDP/FF - 200/6 μg]) (BETRI)
2026年7月30日 更新者：Chiesi Farmaceutici S.p.A.
A Pragmatic, Phase IV, Randomized, Open-label, Multinational, Multicentre, 2-arm Parallel Group, Prospective Study Comparing Efficacy and Safety of Single Inhaler ICS/LABA/LAMA (Beclometasone/Formoterol Fumarate/Glycopyrronium Bromide [87/5/9 pMDI { BD/FF/GB -100/6/12.5 μg} ]) vs Single Inhaler ICS/LABA (Beclometasone Dipropionate Plus Formoterol Fumarate [200/6 pMDI { BD/FF - 200/6 μg} ]) in Asthma Subjects
This study will evaluate the effect of triple ICS/LAMA/LABA therapy with a BDP/FF/GB 100/6/12.5 µg on asthma control outcomes relative to ICS/LABA therapy with BDP/FF 200/6 μg in a population with asthma poorly controlled.
研究概览
地位
招聘中
条件
详细说明
This is a phase IV, pragmatic, randomized, open-label, 2-arm parallel group, multi-center.
The study aims to compare BDP/FF/GB pMDI 100/6/12.5
µg BID with BDP/FF pMDI 200/6 μg BID in adult participants with asthma poorly controlled, using medium dose ICS/LABA for at least 3 months prior randomization.
研究类型
介入性
注册 (估计的)
644
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Clinical Trial INFO Chiesi Farmaceutici S.p.A.
- 电话号码：+39 0521 2791
- 邮箱：clinicaltrials_info@chiesi.com
学习地点
-
-
-
Rousse、保加利亚、7002
- 招聘中
- Medical Center Hermes Ruse LTD 12 Chavdar Voyvoda St.
-
接触：
- Nikolay Evgeniev Nikolaev
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
1 . Study participant's written informed consent obtained prior to any study related procedure.
2. Male or female study participants aged ≥18 years old. 3. Physician confirmed documented asthma diagnosis as per current clinical practice.
4. Stable asthma treatment prior randomisation: At least 3 months on any medium strength (MS) ICS/LABA regular treatment.
5. Poor asthma control at randomisation (ACQ-5 ≥1.5 and at least 1 exacerbation in the previous year).
6. Women with childbearing potential (WOCBP) and with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the last visit.
7. Study participants must have a cooperative attitude and the ability to be trained to use the patient app correctly, to be able to perform the required outcomes measurements (e.g. ePRO completion) and the ability to understand the risks involved.
Note: Study participants with asthma diagnosis and no clinically relevant concurrent COPD diagnosis upon clinical judgement can be included. Study participants on maintenance and reliever therapy (MART) can be included if the ICS dosage does not exceed 400 µg/day of beclometasone or equivalent.
Exclusion Criteria: The presence of any of the following will exclude a study participant from study enrolment:
- Participation in another interventional clinical trial.
- Pregnant or breastfeeding women at the moment of enrolment.
- Other chronic respiratory disease: Lung Cancer, known alpha1-antitrypsin deficiency, active tuberculosis, clinically significant bronchiectasis, interstitial lung disease, pulmonary hypertension, or any other uncontrolled/clinically significant diseases (according to investigator's judgement).
- Contraindication for LAMA use.
- Study participants on biological therapies for asthma.
- For France only: Individuals under court protection (including protected adults) and individuals not affiliated to a social security system are excluded from participation in this study (Country/Region-Specific Differences - France), in accordance with Articles L.1121-6, L.1121-8, and L.1121-8-1 of the French Public Health Code.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：BDP/FF/GB
Trimbow® 87/5/9 pMDI (BDP/FF/GB 100/6/12.5
µg) - 2 inhalations bid
|
Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide BDP/FF/GB (100/6/12.5 µg per actuation) administered via pressurised metered-dose inhaler (pMDI) 2 inhalations bid (i.e. 2 inhalations in the morning and 2 inhalations in the evening) for a total of 12 months.
其他名称：
|
|
有源比较器：BDP/FF
Foster® 200/6 pMDI (BDP/FF 200/6 µg) - 2 inhalations bid
|
Beclometasone dipropionate, formoterol fumarate (BDP/FF-200/6 µg) administered via pressurised metered-dose inhaler (pMDI) 2 inhalations bid (i.e. 2 inhalations in the morning and 2 inhalations in the evening) for a total of 12 months.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in ACQ-5 score
大体时间：Baseline to Month 12 (Visit 7)
|
To demonstrate non inferiority of BDP/FF/GB-100/6/12.5 µg compared to BDP/FF-200/6 µg in terms of change in the Asthma Control Questionnaire-5 (ACQ-5) at Visit 7 (i.e. at Month 12) versus baseline. ACQ-5 is a one-week recall questionnaire including 5 patient-reported questions, each scored on a 7-point scale (0 = no impairment, 6 = maximum impairment). All questions are equally weighted, and the ACQ-5 score is calculated as the mean of the 5 responses, resulting in a total score ranging from 0 (totally controlled) to 6 (severely uncontrolled). |
Baseline to Month 12 (Visit 7)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in ACQ-5 at all applicable visits.
大体时间：Baseline to Month 12 (Visit 7)
|
Change from baseline in ACQ-5 at all applicable visits.
Asthma Control Questionnaire-5 is a one-week recall questionnaire including 5 patient-reported questions, each scored on a 7-point scale (0 = no impairment, 6 = maximum impairment).
All questions are equally weighted, and the ACQ-5 score is calculated as the mean of the 5 responses, resulting in a total score ranging from 0 (totally controlled) to 6 (severely uncontrolled).
|
Baseline to Month 12 (Visit 7)
|
|
Rate of severe asthma exacerbations
大体时间：Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)
|
Rate of severe asthma exacerbations during the 12-month treatment period including specific analysis at 6 and 12 months.
|
Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)
|
|
Rate of moderate/severe asthma exacerbations
大体时间：Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)
|
Rate of moderate/severe asthma exacerbations during the 12-month treatment period including specific analysis at 6 and 12 months
|
Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)
|
|
Time to first severe asthma exacerbation.
大体时间：Month 12 treatment period
|
Time to first severe asthma exacerbation.
|
Month 12 treatment period
|
|
Time to first moderate/severe asthma exacerbation.
大体时间：Month 12 treatment period
|
Time to first moderate/severe asthma exacerbation.
|
Month 12 treatment period
|
|
Speed of change questionnaire at each applicable study visit.
大体时间：Month 12 treatment period
|
Speed of change questionnaire at each applicable study visit.
|
Month 12 treatment period
|
|
Eosinophils value
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Change from baseline in eosinophils value at each applicable study visit.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Chronic Airways Assessment Test (CAAT)
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
CAAT questionnaire consists of 8 items scored from 0 to 5, with a total score ranging from 0 to 40; higher scores indicate worse health status.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Cardiovascular Event Rate
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Percentage of study participants with cardiovascular and/or fatal events (considering standard adverse event [AE] data collection)
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Asthma remission rate
大体时间：Month 6 (Visit 4), Month 12 (Visit 7)
|
Percentage of study participants with partial and complete asthma remission at 6 and 12 months.
|
Month 6 (Visit 4), Month 12 (Visit 7)
|
|
Change in Spirometry parameters: FEV1
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: FEV1 (forced expiratory volume in 1 second), expressed as volume (L).
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Spirometry parameters: FVC
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: FVC (forced vital capacity), expressed as volume (L).
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Spirometry parameters: FEV1/FVC ratio
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: FEV1/FVC ratio, expressed as a percentage (%).
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Spirometry parameters: FEF25-75
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: FEF25-75 (forced expiratory flow between 25% and 75% of FVC), expressed as flow (L/s).
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Spirometry parameters: ratio of FEF25-75 to FVC
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: ratio of FEF25-75 to FVC.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Spirometry parameters: FEV1%
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: FEV1 as percentage of predicted normal values (%).
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Spirometry parameters: FVC% of predicted normal
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by spirometry: FVC as percentage of predicted normal values (%).
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Oscillometry parameters- R5 (Total airway resistance)
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by oscillometry: Resistance at 5 Hz (R5), representing total airway resistance, expressed in kPa·L-¹·s.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Oscillometry parameters- R20 (Central airway resistance)
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by oscillometry: Resistance at 20 Hz (R20), representing central airway resistance, expressed in kPa·L-¹·s.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Oscillometry parameters- R5-R20 (Peripheral airway resistance)
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by oscillometry: Difference between resistance at 5 Hz and 20 Hz (R5-R20), representing peripheral airway resistance, expressed in kPa·L-¹·s.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Oscillometry parameters-X5 (Reactance)
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by oscillometry: Reactance at 5 Hz (X5), reflecting distal airway reactance, expressed in kPa·L-¹·s.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Oscillometry parameters-Fres (Resonant frequency)
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by oscillometry: Resonant frequency (Fres), defined as the frequency at which reactance equals zero, expressed in Hz
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in Oscillometry parameters-AX (Area of reactance)
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Pulmonary function tests measured by oscillometry: Area of reactance (AX), representing the integrated low-frequency reactance, expressed in Hz·kPa·L-¹·s.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Oral systemic corticosteroids days
大体时间：Month 12 treatment period
|
Number of days with oral systemic corticosteroids
|
Month 12 treatment period
|
|
Change from baseline in Test of Adherence to Inhalers (TAI) questionnaire at each applicable visit.
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
Test of Adherence to Inhalers (TAI) questionnaire change.
The TAI-10 score is automatically calculated on the electronic device by summing the individual item scores (1-10) ranging from 10-50, with higher score indicating better adherence.
The TAI 12-item total score is derived manually as sum of TAI-10 total score and items 11 and 12 scores.
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Change in quality-of-life questionnaire: EQ-5D-5L
大体时间：Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
EQ-5D-5L = EuroQol 5-Dimension 5-Level: index values range from <0 to 1 (higher values indicate better health), and EQ VAS scores range from 0 to 100 (higher scores indicate better self-rated health).
|
Month 0 Baseline (Visit 1), Month 2 (Visit 2), Month 4 (Visit 3), Month 6 (Visit 4), Month 8 (Visit 5), Month 10 (Visit 6), and Month 12 (Visit 7)
|
|
Oral systemic corticosteroids dose
大体时间：Month 12 treatment period
|
Dose of oral systemic corticosteroids (mg)
|
Month 12 treatment period
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月28日
初级完成 (估计的)
2028年6月13日
研究完成 (估计的)
2028年6月13日
研究注册日期
首次提交
2026年5月21日
首先提交符合 QC 标准的
2026年6月19日
首次发布 (实际的)
2026年6月24日
研究记录更新
最后更新发布 (实际的)
2026年7月31日
上次提交的符合 QC 标准的更新
2026年7月30日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CLI-05993AB1-08
- 2025-524289-56-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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