Randomized, Parallel-group Trial to Evaluate Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of total subjects that had to stop treatment early between groups
研究概览
简要总结
The purpose of this study is to assess the feasibility, safety and efficacy of a combination of nebulized Formoterol and Revefenacin among patients hospitalized for AECOPD compared with standard-of-care therapy with nebulized Albuterol and Ipratropium.
详细描述
A prospective, parallel group, randomized clinical trial in 60 patients hospitalized with the primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD (ICD-10 codes J44.1 and J96 - J96.2 with J44.9).
The plan is to:
Administer standard bronchodilator protocol with nebulized Albuterol and Ipratropium every 6 hours (n=30)
versus
Nebulized Revefenacin 175 μg once per day and Formoterol 20 μg twice per day (n=30) for up to 7 days of treatment. Study medication will be administered by standard jet nebulizers in both groups.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •≥ 40 years of age
- •Admitted to the hospital with a primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD
- •Able to understand and comply with study procedures
- •Willingness to sign and date an Informed Consent Form
排除标准
- •Patients unable or unwilling to sign an informed consent or cooperate with study procedures
- •Patients who are hypersensitive to Formoterol or Revefenacin
- •Patients who are intubated, have tracheotomy, are receiving mechanical ventilation by mask or artificial airway
- •Patients, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support
- •Patients who, per the investigator, have unstable cardiovascular disease (e.g., uncontrolled, hypertension, unstable angina, recent MI (within 12 weeks), ventricular arrhythmia, or decompensated heart failure)
- •Patients with a current diagnosis of lung cancer requiring treatment
- •Patients that test positive for COVID-19
- •Pulmonary diseases other than COPD, or lobar pneumonia
- •Patients with acute psychiatric illness deemed significant by the investigator
- •Patients with a history of glaucoma deemed significant by the investigator
- •History of urinary retention deemed significant by the investigator
- •12 Women who are pregnant or breast feeding
研究组 & 干预措施
Group 1: Revefenacin (YUPELRI) & Formoterol (Perforomist)
Revefenacin 175 μg once per day and Formoterol 20 μg twice per day via jet nebulizer for 7 days or until discharge if prior to day 7.
干预措施: Revefenacin (YUPELRI) & Formoterol (Perforomist) (Drug)
Group 2: Ipratropium Bromide (Atrovent) & Albuterol (Ventolin) as Standard of Care
Albuterol and Ipratropium every 6 hours nebulized over the 7-day treatment period or until discharge if prior to day 7.
干预措施: Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic) (Drug)
结局指标
主要结局
Number of total subjects that had to stop treatment early between groups
时间窗: Through study completion, up to 7 days
Total percent of patients that had to switch therapy due to lack of response between each group.
The total number of subjects with Adverse Events, SAE's, ET, and Deaths between groups.
时间窗: Through study completion, up to 7 days
Adverse Events, SAE's, ET, and Deaths will be recorder for every subjects in both groups until the end of their study participation.
Difference in Borg Dyspnea Scale scores between groups
时间窗: change from day 3 borg dyspnea score at day 7
This is a scale asks the subject to rate the difficulty of their breathing. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal. This will be recorded prior to dosing twice a day between 7 and 9 am \& pm. Scores from Group 1 and Group 2 will be averaged and compared.
The difference in the lowest level of FiO2 employed at each visit between group 1 and group 2
时间窗: at day 7
The lowest level of FiO2 will be recorded from the subjects EMR record at each visit during study participation and the difference between group 1 and group 2 will be noted.
Difference in the mean total doses of short acting bronchodilators (rescue) used during study participation between each group.
时间窗: up to 7 days
Subject in both groups will be allowed to use standard of care rescue short-acting bronchodilators throughout their study participation.
Difference in Modified Borg Dyspnea Scale Scores Between Groups
时间窗: From enrollment to the end of treatment at Day 7
The Modified Borg Dyspnea Scale asks the subject to rate the difficulty of their breathing. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal. This scale was recorded prior to dosing twice a day between 7 and 9 am \& pm.
次要结局
- Total Number of Rescue Doses Administered During the Hospital Stay in Patients With Exacerbations of COPD(From enrollment to the end of treatment at Day 7)
- Number of Patients Needing to Switch/Change Their Treatment Regimen(From enrollment to the end of treatment at Day 7)
- Number of Participants With Failure of Treatment (Need for Mechanical Ventilation or Death)(From enrollment to the end of treatment at Day 7)
- Need for Supplemental Oxygen by Nasal Cannula (L/Min) Among Patients With Exacerbations of COPD(Days 1 and 3)
- Total Visits for Study Drug Administration Per Day Received by Each Patient(From enrollment to the end of treatment at Day 7)
- Total Doses of Bronchodilators Per Hospital Stay(From enrollment to the end of treatment at Day 7)