A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma (study 205715) - study 205715

GlaxoSmithKline0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•* Inadequately controlled asthma (ACQ-6 score *1.5) at Visit 2.
•* A best pre-bronchodilator morning (AM) FEV1 *30% and <85% of the predicted normal value at Visit 2. Predicted values will be based upon the ERS Global Lung Function Initiative.

•* Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject*s asthma status or the subject*s ability to participate in the study.
•* Evidence of a severe exacerbation during screening or the run-in period, defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days (1) or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
•(1) For subjects on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required.
•* Changes in asthma medication (excluding run-in medication and salbutamol inhalation aerosol provided at Visit 1).
•* Pregnancy or breastfeeding.

发起方