Bronchodilation following repeated administration of budesonide/formoterol vs salbutamol in adult asthma: A randomised, open-label, cross-over study

Medical Research Institute of New Zealand0 个研究点目标入组 39 人开始时间: 2019年8月6日最近更新: 2022年8月15日

适应症

试验速览

暂无简介。

•Doctor diagnosis of asthma.
•Age 16 to 65 years.
•SABA monotherapy or SABA with regular ICS therapy, or regular ICS/LABA treatment
•FEV1 40 to 70% predicted as per GLI 2012 criteria
•Change in FEV1 post 400µg salbutamol via MDI through a spacer >12% increase from baseline, and >200ml

•Other significant respiratory disorder
•Other significant cardiovascular disorder such as history of arrhythmia including atrial fibrillation and supraventricular tachycardia
•Current or recent respiratory tract infection in last 4 weeks
•Current use of other asthma medications including LAMAs, theophylline, oral corticosteroids, biologics, sodium cromoglycate or nedocromil sodium
•Asthma exacerbation requiring oral steroids in last 6 weeks
•Current smoker or smoking history with >10 pack year history
•QTCF > 430ms for men and > 450ms for women
•Pregnant, or planning a pregnancy, or breast feeding
•Allergy to investigational products, including previous adverse effects following administration of similar doses to those used in the study
•Current use of beta-blockers
•Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.

发起方