Идёт набор NCT07301736

Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma

Фаза II С лечением Asthma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: CHF5993 pMDI with HFA-152a, CHF5993 pMDI with HFA-134a, CHF718 pMDI with HFA-134a.
Кому может быть актуально: Состояния в реестре: Asthma. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Аргентина, Bosnia and Herzegovina, Болгария, Чехия, Германия +9
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase II Multinational, Multicentre, Double-blind, Randomised, Active-controlled, 3-way Cross-over Study to Evaluate the Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a Versus CHF5993 pMDI 100/6/12.5 µg HFA-134a in Subjects With Mild to Moderate Asthma

Обзор

This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.

Подробное описание

This global study aims to compare whether the investigational inhaler with the new HFA-152a propellant is as safe, effective and well tolerated in patients with asthma as the inhalers that use the existing HFA-134a propellant. HFA-152a is a propellant gas that is designed to have a lower global warming potential and to be more climate friendly. The study will be conducted in Europe, Latin America, Ukraine, South Africa and United Kingdom. It is planned to randomize 468 patients.

Вмешательства

Препарат CHF5993 pMDI with HFA-152a
two puffs BID (twice daily)
Препарат CHF5993 pMDI with HFA-134a
two puffs BID
Препарат CHF718 pMDI with HFA-134a
two puffs BID

Первичные конечные точки

Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from time zero to 4 hours (AUC0-4h) on Day 1 [Срок оценки: Day 1]
Change from baseline in pre-dose FEV1 on Day 28 [Срок оценки: Day 28]

Критерии участия

Критерии включения

Male and female adults (18 ≤ age ≤ 75 years) with a diagnosis of Asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years;
Non-smokers, ex-smokers;
Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive;
Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with:

low or medium doses of ICS (Inhaled Corticosteroids) alone; or
low or medium doses of ICS + LABA (Long-acting β2-agonist) (fixed or free combination).
Controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score <1.5 at screening and at randomisation.
Pre-BD (Bronchodilator) FEV1 >40% and <90% of the predicted normal value, after appropriate wash out from BDs, at the Screening Visit (V1).
A demonstrated increase in either FEV1 or forced vital capacity of >12% and >200 mL from baseline within 30 minutes (min) after inhalation of 400 µg salbutamol (i.e. albuterol) pMDI at the Screening Visit (V1).

Критерии исключения

History of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the previous 6 months prior to screening, which in the judgement of the Investigator may place the subjects at undue risk;
Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to screening and/or during the run-in period ;
Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine;
Asthma subjects currently treated with any of the following :

High dose ICS;
Long-acting muscarinic antagonist (LAMA);
Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening;
Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening;
Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening;
Respiratory disorders other than asthma
Lung resection;
Lower respiratory tract infection;
Lung cancer and history of lung cancer;
Subjects with active cancer or a history of cancer (other than lungs) ;
Patients who have clinically significant cardiovascular condition;
Run-in compliance: e-Diary completion <75% and run-in treatment compliance <75% at randomisation;

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Перекрёстный дизайн
Маскирование: Четверное слепое
Основная цель: Лечение

Центры проведения

Аргентина · 27 центров

Hospital Británico de Buenos Aires_Site n. 032029 — Buenos Aires
Centro Medico de Enfermedades Respiratorias_Site n. 032002 — Buenos Aires
Centro Medico Respire_Site n. 032014 — Buenos Aires
Asociación de Fomento y Sala de Primeros Auxilios "Alberto Mignaburu"_Site n. 032018 — Buenos Aires
Centro de Investigaciones Médicas Mar del Plata_Site n. 032019 — Buenos Aires
Fundacion CIDEA_Site n. 032009 — Buenos Aires
Centro Medico Arsema_Site n. 032003 — Buenos Aires
Centro de Investigaciones Metabólicas (CINME)_Site n. 032025 — Ciudad Autonoma de Buenos Aire
… и ещё 19 центров

Болгария · 21 центр

MHAT Sv. Ivan Rilski - Gorna Oryahovitsa_Site n.100017 — Gorna Oryahovitsa
Medical Center Pulmo - 2018_Site n. 100007 — Haskovo
MC ZDRAVE 1 - Kozloduy_Site n. 100009 — Kozloduy
Medical Centre Pratia Clinic EOOD - Lovech_Site n. 100012 — Lovech
Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik EOOD_Site n. 1000 — Pernik
Multiprofile Hospital for Active Treatment "Heart and Brain" EAD_Site n. 100019 — Pleven
Medical Centre ''Unimed'' EOOD_Site n. 100003 — Plovdiv
MHAT "St. Ivan Rilski "- Razgrad_Site 100013 — Razgrad
… и ещё 13 центров

Германия · 19 центров

Velocity Clinical Research Germany, Ahrensburg_Site n. 276020 — Ahrensburg
Studienpraxis Berlin-Brandenburg_Site n. 276005 — Berlin
Praxis an der Oper_Site n. 276016 — Berlin
Lungenpraxis Hohenzollerndamm_Site n. 276004 — Berlin
Velocity Clinical Research Germany GmbH_Site 276010 — Berlin
Polikum Institut GmbH_Site n. 276006 — Berlin
Institute for Allergy and Asthma Research Berlin, IAAB_Site n. 276008 — Berlin
MECS research GmbH_Site 276011 — Berlin
… и ещё 11 центров

Украина · 15 центров