A Randomized, Double-blind, Two Treatment, Two Period, Chronic dosing (4 weeks), Crossover, Multi-center Pilot study to evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate and Glycopyrronium/Formoterol Fumarate on Specific Image based Airway Volumes and Resistance in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease - FRI in COPD

Astra Zeneca0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月15日

试验速览

暂无简介。

•- Subject must be 40 years to *80 years of age inclusive, at the time of
•signing the informed consent form at Visit 1., - COPD Diagnosis: Subjects with
•an established clinical history of COPD , - Screening clinical laboratory tests
•must be acceptable to the Investigator., - Screening ECG must be acceptable to
•the Investigator, - Individual Compliance: Subjects must be willing to remain
•at the study center as required per protocol to complete all visit assessments,
•- Patients should be on scheduled maintenance treatment with one or more
•inhaled bronchodilator therapies.

•- As judged by the investigator, any evidence of significant diseases other
•than COPD, i.e., disease or condition which, in the investigator*s opinion
•makes it undesirable for the subject to participate in the trial., - Spirometry
•Performance:
•1) Subjects who cannot perform acceptable spirometry, i.e., meet ATS/ERS
•acceptability criteria., 2) Repeatability: Subjects who cannot perform
•technically acceptable spirometry in accordance with ATS repeatability criteria
•, - Cancer: Subjects who have cancer that has not been in complete remission
•for at least five years., - Substance Abuse: Subjects, who in the opinion of
•the Investigator, significantly abuse alcohol or drugs, - Subjects who in the
•opinion of the investigator are unable to abstain from prohibited medications
•including LABA/LAMAs/ICS

发起方

Astra Zeneca