A 12-week, randomized, participant-and investigator-blinded, placebo-controlled, parallel group study to explore the efficacy, pharmacodynamics, safety, and pharmacokinetics of two doses of inhaled CSJ117 in adults with Chronic Obstructive Pulmonary Disease (COPD)

ovartis Pharma AG0 个研究点目标入组 300 人开始时间: 2021年11月1日最近更新: 2022年3月28日

研究概览

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•--Male and female COPD patients aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
•--Current or ex-smokers who have a smoking history of at least 10 pack years
•--Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last 3 months prior to screening
•--Patients with a documented diagnosis of COPD for at least 1 year prior to screening visit
•Other protocol-defined inclusion criteria may apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•--Patients with a past or current medical history of asthma
•--Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or hospitalization between screening and prior to treatment.
•--Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics),
•whichever is longer; or longer if required by local regulations
•--Pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation
•-Patients with a body mass index (BMI) of more than 40 kg/m2
•Other protocol-defined exclusion criteria may apply

发起方