Comparison of two formulations of beclometasone/formoterol pMDI on respiratory system impedance using impulse oscillometry in asthmatic patients. - CLI-01535AC1-03_Foster1

CHIESI FARMACEUTICI S.p.A0 个研究点目标入组 24 人开始时间: 2018年7月26日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•- Male or female patients aged 18 years and above.
•- Patient’s written informed consent obtained prior to any study related procedures.
•- Patients with established diagnosis of persistent asthma for at least 6 months according to international guidelines.
•- Patients on 400-2000µg BDP equivalent of Inhaled Corticosteroids (ICS) per day +/- 2nd/3rd line therapy.
•- Patients with Forced Expiratory Volume in 1 second (FEV1) = 60% predicted at screening.
•- Patients with methacholine PC40 R5 = 8mg/ml at screening.
•- Non- or ex-smokers who smoked = 5 Pack-years and quitted smoking > 1 year prior to screening
•- Female patients must be either of non-childbearing potential or childbearing potential fulfilling one of the following criteria:
•o 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 follow-up contact or
•o with non-fertile male partners (contraception is not required in this case).
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 18
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•- Patients with any other respiratory diseases such as Chronic Obstructive Pulmonary Disease, bronchiectasis or Allergic Bronchopulmonary Aspergillosis, which in the opinion of the investigator are
•considered to be clinically significant and may have an impact on the study outcomes.
•- Patients with an asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement or 3 months if hospital admission was required or during the run-in period.
•- Exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine.
•- Patients with any known systemic clinically significant medical condition, and communicable disease that may endanger the health or safety of the patients.
•- Female patients who are pregnant or lactating.

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