Effect of the Aerobika Oscillating Positive Expiratory Pressure (OPEP) Device on Mucus Plugging and Airflow Obstruction in Patients with Moderate-to-severe Asthma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Computed Tomography (CT) mucus score
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate the effect of daily AerobikaTM Oscillating Positive Expiratory Pressure (OPEP) device use on mucus plugging and airway function in adult patients with moderate-to-severe asthma.
详细描述
Airway mucus occlusions have been identified as an important feature of asthma pathophysiology. The use of an airway clearance device may help clear such mucus plugs and consequently improve airway function and asthma control. Therefore, we will investigate the effects of daily Aerobika Oscillating Positive Expiratory Pressure (OPEP) device use in a two-centre, randomized, open-label study of adult patients with moderate-to-severe asthma that is uncontrolled with evidence of mucus plugging.
The total study duration per patient will be 17 weeks, consisting of a screening period of up-to 1 week, and an open-label randomized treatment period of 16 weeks. Participants will be randomized to Aerobika use or will continue their current medications. The trial will evaluate the effect of Aerobika use on mucus plugging, airway function, and asthma control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide written informed consent.
- •Able and willing to comply with the study protocol.
- •Males and females ≥ 18 years of age.
- •Asthma diagnosed by a respiratory physician ≥12 months prior to study enrolment based on the Global Initiative for Asthma (GINA) 2014 guidelines - GINA 4 or
- •ICS dose ≥500 mcg of fluticasone equivalent/day. Patients on prednisone or biologic for ≥3 months would not be excluded as long as they meet the rest of the inclusion criteria.
- •ACQ ≥1.5 during the screening period.
- •CT mucus score ≥4 during the screening period.
排除标准
- •Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently requires, hospitalization or antimicrobial treatment during the last four weeks.
- •Acute asthma exacerbation event treated with increased doses of oral, or any dose of intramuscular (IM) or intravenous (IV) corticosteroids within six weeks prior to screening.
- •Other relevant pulmonary diseases (e.g., chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, tuberculosis) requiring treatment within 12 months prior to screening.
- •Alcohol or substance abuse within 12 months prior to screening.
- •Current smoker defined as having smoked at least one cigarette (or pipe, cigar, or cannabis) per day for ≥ 30 days within the three months prior to screening.
- •Ex-smokers with ≥ 15 pack-year smoking history.
- •Patient has an implanted mechanically, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) (at the discretion of the MRI Technologist).
- •In the investigator's opinion, subject suffers from any physical, psychological, or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
- •Pregnant or breastfeeding
- •Participation in any clinical trial of an investigational agent or procedure within three months prior to screening or during the study.
结局指标
主要结局
Computed Tomography (CT) mucus score
时间窗: 16 weeks
Change in the CT mucus score between screening/baseline (week 0) and week 16. Mucus scores range from 0 (best outcome) to 20 (worst outcome).
次要结局
- Asthma Quality of Life Questionnaire (AQLQ)(16 weeks)
- MRI ventilation defect percent (VDP)(16 weeks)
- sputum neutrophil percent(16 weeks)
- St. George's Respiratory Questionnaire (SGRQ)(16 weeks)
- Forced expiratory volume in one second (FEV1)(16 weeks)
- Asthma Control Questionnaire-5 (ACQ-5)(16 weeks)
- Asthma Control Test (ACT)(16 weeks)
- fraction of exhaled nitric oxide (FeNO)(16 weeks)
- Cough and Sputum Assessment Questionnaire (CASA-Q)(16 weeks)
- blood eosinophil count(16 weeks)
- respiratory system resistance (Rrs) at 5Hz(16 weeks)
- respiratory system resistance (Rrs) at 19Hz(16 weeks)
- integrated area of low frequency reactance (AX)(16 weeks)
- sputum eosinophil percent(16 weeks)
- respiratory system reactance (Xrs) at 5Hz(16 weeks)
- inspiratory CT wall area percent (WA%)(16 weeks)
- inspiratory CT lumen area (LA)(16 weeks)
- frequency dependence of Rrs (Rrs5-19Hz)(16 weeks)
研究者
Sarah Svenningsen
Principal Investigator
St. Joseph's Healthcare Hamilton