NCT07666490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
- 644
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 . Study participant's written informed consent obtained prior to any study related procedure.
- •2. Male or female study participants aged ≥18 years old.
- •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.
排除标准
- •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.
研究组 & 干预措施
BDP/FF
Active Comparator
Foster® 200/6 pMDI (BDP/FF 200/6 µg) - 2 inhalations bid
干预措施: Foster® 200/6 pMDI (BDP/FF-200/6 µg) (Drug)
BDP/FF/GB
Active Comparator
Trimbow® 87/5/9 pMDI (BDP/FF/GB 100/6/12.5 µg) - 2 inhalations bid
干预措施: Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100/6/12.5 µg per actuation) (Drug)
结局指标
主要结局
未指定
次要结局
- Change from baseline in Test of Adherence to Inhalers (TAI) questionnaire at each applicable 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 quality-of-life questionnaire: EQ-5D-5L(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(Month 12 treatment period)
- Oral systemic corticosteroids dose(Month 12 treatment period)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
3 期
A Study Evaluating the Efficacy of Breztri/Trixeo on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary DiseaseCTRI/2024/12/078263AstraZeneca AB5,000
招募中
1 期
A Single Centre, Open-label, 2-period Fixed-sequence, Phase I Clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Polymyxin B in Healthy VolunteersHealthy Adult ParticipantsNCT07580586BioVersys SAS16
招募中
3 期
A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (CLE) (AMETHYST LTE)2023-504863-17-00Biogen Idec Research Limited204
已完成
不适用
Bioequivalence study of Barnidipine Hydrochloride Modified-Release Capsules 20 mg in healthy human subjectsCTRI/2025/12/099080Centaur Pharmaceuticals Pvt. Ltd., India16
尚未招募
2 期
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African ChildrenNCT07320716GlaxoSmithKline528