A Multicenter, Prospective, Open Label, Single arm, Phase IV Study to Assess the Safety and Effectiveness of Fixed Dose Combination of Vilanterol Trifenatate eq. to 25 mcg Vilanterol 40 mcg and Glycopyrronium Bromide eq. to 50 mcg Glycopyrronium 63 mcg Powder for Inhalation in Capsule indicated as maintenance treatment for Patients with Chronic Obstructive Pulmonary Disease. - NA

upin Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•1.Males and females aged 18 years and above.
•2.mMRC =2 even after receiving monotherapy (LABA or LAMA) or dual therapy (LABA + ICS) for at least 4-6 weeks at the time of screening.
•3.COPD Assessment Test (CAT) score = 10 even after receiving monotherapy (LABA or LAMA), dual therapy (LABA + ICS) for at least 4-6 weeks at the time of screening.
•4.Willing to take the medications as directed.
•5.Willing to comply with the protocol requirements.
•6.Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures.
•7.Post-menopausal female patients, or female of child bearing age must agree to use highly effective contraceptive measures with her partner during the study and for 90 days following their last dose

•1.Known hypersensitivity to Glycopyrronium, Vilanterol, other beta-2 agonists, other anti-muscarinic agents, or excipients of formulation.
•2.Known a1-antitrypsin deficiency.
•3.Known history of HIV or HBV or HCV infection
•4.COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period.
•5.Hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period.
•6.Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period.
•7.Known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention.
•8.Clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy.
•9.Known history of hepatic dysfunction.
•10.With continuing history of alcohol and/or drug abuse.
•11.Not willing to give written informed consent.
•12.Any other condition/ uncontrolled co-morbid conditions that, in the opinion of the investigator, does not justify the inclusion of the patient in the study.
•13.Pregnant women.
•14.Lactating females.

发起方

upin Ltd