Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists

Официальное название

A 24 Week, Randomised, Double Blind, Multicentre, Active Controlled, 2-arm, Parallel Group Trial Comparing Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to CHF 1535 100/6 μg HFA-134a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate) in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists

Обзор

This is a study comparing CHF 5993 pMDI HFA-152a with CHF 1535 pMDI HFA-134a in Chinese patients with asthma uncontrolled on medium doses of ICS+LABA.

Подробное описание

The study will be conducted at sites in China. The study will be composed of a run-in period with CHF 1535 pMDI HFA-134a (reference product) followed by a 24-week randomised treatment period when CHF 5993 pMDI HFA-152a (test product) or the reference product will be administered. Total study duration is 27 weeks. AEs and SAEs will be monitored from the informed consent signature until the subject's study participation ends, including AEs of particular interest such as cough. Serial spirometry will be performed both for subjects under study treatment as well as for subjects that discontinued the study treatments but continued the study using a different medication

Вмешательства

• Препарат Experimental: Participant Group CHF 5993 pMDI HFA-152a
  total daily dose of BDP/FF/GB:400/24/50 μg Administration: Two (2) inhalations twice daily(BID) (i.e., 2 inhalations in the morning and 2 inhalations in the evening), total daily dose of BDP/FF/GB: 400/24/50 μg (subjects used to inhaling their asthma pMDI medications with a spacer should continue using the spacer AeroChamber Plus Flow Vu AntiStaticTM to take the pMDI study treatments)
• Другое Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a
  total daily dose of BDP/FF: 400/24 μg Administration: Two (2) inhalations BID (i.e., 2 inhalations in the morning and 2 inhalations in the evening), total daily dose of BDP/FF: 400/24 μg (subjects used to inhaling their asthma pMDI medications with a spacer should continue using the spacer AeroChamber Plus Flow Vu Anti-StaticTM to take the pMDI study treatments).

Первичные конечные точки

• Peak FEV1 [Срок оценки: At week 24]

Вторичные конечные точки (8)

• Peak FEV1, FEV1, FEV1 area under curve(AUC)0-3h normalised by time [Срок оценки: up to 24 weeks]
• PEF [Срок оценки: at week 24]
• ACQ-7 score [Срок оценки: up to 24 weeks]
• Average use of rescue medication [Срок оценки: at week 24]
• The number of moderate and severe exacerbations [Срок оценки: at week 24]
• Time to first moderate or severe exacerbation [Срок оценки: at week 24]
• Average daily (morning and evening) asthma symptoms [Срок оценки: at week 24]
• Percentage of asthma control days [Срок оценки: at week 24]

Критерии участия

Критерии включения

• Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:

• Subjects must provide written informed consent prior to any study-related procedures;
• Subjects must be male or female Chinese aged ≥18 and

≤75 years;

• Subjects must have a documented history of asthma for at least 1 year and asthma must have been diagnosed before the subject's age of 40;
• Subjects must have uncontrolled asthma, receiving double therapy only on medium doses of ICS in combination with LABA at a stable dose for at least 4 weeks prior to screening;
• Subjects must have a pre-bronchodilator FEV1 <80% of their predicted normal value, after appropriate wash out from bronchodilators at the screening visit.
• Subjects must have a positive response to a reversibility test at screening.
• Subjects must have uncontrolled asthma evidenced by a score at the ACQ-7 ≥1.5 (this criterion must be met at screening and at randomisation).

Критерии исключения

• Subjects meeting any of the following criteria will be excluded from study enrolment:

• Subjects who have a history of near fatal asthma or of a past hospitalisation for status asthmaticus or severe asthma exacerbation which, in the judgement of the Investigator, may place the subject at undue risk;
• Subjects who have undergone hospitalisation, emergency room visit or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to the screening visit or during the run-in period;
• Subjects with any asthma exacerbation or respiratory tract infection in the 4 weeks prior to the screening visit or during run-in period;
• Subjects with any change in dose, schedule or formulation of the combination ICS+LABA in the 4 weeks prior to the screening visit;
• Subjects who have used systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks prior to screening;
• Subjects who have a history of a diagnosis of chronic obstructive pulmonary disease (COPD) (according to the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] document), cystic fibrosis, bronchiectasis or alpha- 1 antitrypsin deficiency or any other significant lung disease which may interfere with study evaluations;
• Subjects who are current smokers; ex-smokers with total cumulative exposure ≥10 pack-years; having stopped smoking 1 year or less prior to the screening visit;
• Subjects who are treated with monoclonal antibodies (e.g., anti-immunoglobulin (Ig)E or anti-IgG antibodies) or biological drugs;
• Subjects who have received an investigational drug within 2 months or six half-lives (whichever is greater) prior to the screening visit, or have been previously randomised in this study, or are currently participating in another clinical study.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• China-Japan Friendship Hospital — Пекин
• China-Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT07546981 · CLI-05993AA5-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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