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])

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100/6/12.5 µg per actuation)
  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.
• Препарат Foster® 200/6 pMDI (BDP/FF-200/6 µg)
  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.

Первичные конечные точки

• Change in ACQ-5 score [Срок оценки: Baseline to Month 12 (Visit 7)]

Вторичные конечные точки (12)

• Change from baseline in ACQ-5 at all applicable visits. [Срок оценки: Baseline to Month 12 (Visit 7)]
• Rate of severe asthma exacerbations [Срок оценки: Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)]
• Rate of moderate/severe asthma exacerbations [Срок оценки: Month 12 treatment period and Baseline to Month 6 (Visit 4) and Month 12 (Visit 7)]
• Time to first severe asthma exacerbation. [Срок оценки: Month 12 treatment period]
• Time to first moderate/severe asthma exacerbation. [Срок оценки: Month 12 treatment period]
• Speed of change questionnaire at each applicable study visit. [Срок оценки: Month 12 treatment period]
• Eosinophils value [Срок оценки: 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 [Срок оценки: Month 12 treatment period]
• Change from baseline in Test of Adherence to Inhalers (TAI) questionnaire at each applicable visit. [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Болгария · 1 центр

• Medical Center Hermes Ruse LTD 12 Chavdar Voyvoda St. — Rousse

Идентификаторы

NCT: NCT07666490 · CLI-05993AB1-08 · 2025-524289-56-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗