A Randomized Multicenter Open Label Study to Evaluate the Efficacy and Safety of Aerobika Oscillating Positive Expiratory Pressure OPEP Therapy Versus Standard of Care in Adults with Bronchiectasis - AB OPEP Bronchiectasis study

Trudell Medical International0 个研究点目标入组 100 人开始时间: 2026年8月1日最近更新: 2026年8月3日

试验速览

暂无简介。

•1.Diagnosis of bronchiectasis by HRCT of the chest
•2.Documented Gram-negative bacterial infection of the respiratory tract
•3.At least one documented bronchiectasis exacerbation requiring systemic antibiotics or systemic corticosteroids within the 12 months prior to screening
•4.Clinically stable for at least 4 weeks prior to randomization
•5.Able to perform and reproducibly complete spirometry according to ATS ERS criteria
•6.Provision of written informed consent prior to any study specific procedure
•7.Patients have never used any kind of OPEP device in the past.

•1.History of pneumothorax within the preceding 3 months or known bullous emphysema constituting a contraindication to positive pressure techniques
•2.Massive hemoptysis within the preceding 3 months
•3.Significant neuromuscular or cognitive impairment precluding safe and effective device use as judged by the investigator
•4.Current enrolment in another interventional randomized control trial
•5.Pregnancy or planned pregnancy during the study period or breastfeeding
•6.Any other medical condition that in the opinion of the investigator would prevent safe participation or confound study interpretation

发起方

Trudell Medical International