2025-524289-56-00招募中4 期
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.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 606
- 试验地点
- 89
研究概览
简要总结
To demonstrate noninferiority of Trimbow® 87/5/9 pMDI (BDP/FF/GB-100/6/12.5 µg) compared to Foster® 200/6 pMDI (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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Open-label
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Study participant’s written informed consent obtained prior to any study related procedure.
- •Male or female study participants aged ≥18 years old.
- •Physician confirmed documented asthma diagnosis as per current clinical practice.
- •Stable asthma treatment prior randomisation: At least 3 months on any MS ICS/LABA regular treatment.
- •Poor asthma control at randomisation (ACQ-5 ≥1.5 and at least 1 exacerbation in the previous year).
- •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.
- •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. electronic patient-reported outcome [ePRO] completion) and the ability to understand the risks involved. Note: Study participants with asthma diagnosis and no clinically relevant concurrent chronic obstructive pulmonary disease diagnosis upon clinical judgement can be included. Study participants on maintenance and reliever therapy can be included if the ICS dosage does not exceed 400 µg/day of beclometasone or equivalent.
排除标准
- •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 long-acting muscarinic antagonists 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, as detailed in Appendix 4 (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.
研究组 & 干预措施
Fostair 200 microgram/6 microgram per actuation pressurised inhalation solution
Comparator
干预措施: Fostair 200 microgram/6 microgram per actuation pressurised inhalation solution (Drug)
Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution
Test
干预措施: Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution (Drug)
研究者
Clinical Project manager
Scientific
Chiesi Farmaceutici S.p.A.
研究点 (89)
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