Formoterol-beclomethasone in patients with bronchiectasis: a randomized, double-blind, placebo-controlled trial (Forza study) - FORZA study

Erasmus MC0 个研究点目标入组 72 人开始时间: 2018年7月6日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•·Age = 18 years;
•·Symptomatic patient (wheezing, cough and dyspnoea);
•·Proven and documented diagnosis of BE by high resolution computed tomography
•·Stable pulmonary status as indicated by FEV1 (percent of predicted) =30% and <90% (post-bronchodilator);
•·Stable clinically phase (ie, subjects free from acute exacerbation for at least 6 weeks prior to the start of the study);
•·Stable regimen of standard treatment if used as chronic treatment for BE, at least for the past 4 weeks prior to screening. And/or macrolides if used as chronic treatment for BE at least for the past 6 months prior to screening;
•·Coughing on the majority of days.
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 32

•-Possible asthma according to the definition of the Global Initiative for Asthma (GINA) with:
•oPositive bronchodilator reversibility test (increase in FEV1 of >12% and >200 mL from baseline, 10–15 minutes after 200–400 mcg salbutamol or equivalent)OR
•o Positive bronchial challenge test (fall in FEV1from baseline of =20% with standard doses of methacholine or histamine)
•-Known intolerance for ICS or LABA.
•-Other cardiopulmonary conditions (other than bronchiectasis) that could modify spirometric valeus.
•-Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
•-Cigarette smoking history of > 10 pack-years and/or current smokers;
•-Expected to die within 72 hours after enrolment.
•- Current ICS use

发起方