A Randomized, Double-Dummy, Crossover, Single-Center Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers in the Treatment of Patients Recovering From Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The Difference Between the Values of Area Under the Response Curve for FEV1
研究概览
简要总结
The purpose of this study is to compare drug delivery and lung function after treatment with formoterol from a nebulizer versus a dry powder inhaler (DPI) in patients recovering from severe exacerbations of COPD. This is to determine if one device is superior in providing better lung function and drug deposition in this clinical setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Current or past cigarette smoking history of >/= 10 pack-years.
- •FEV1/FVC ratio </= 70%.
- •Known diagnosis of COPD.
- •Current hospitalization for a primary diagnosis of acute exacerbation of COPD.
- •Must be able to understand and willing to sign an informed consent document.
排除标准
- •On a ventilator or mask ventilation.
- •Allergy or contraindication to Formoterol use.
- •Marked QTc prolongation (> 450 ms).
- •Liver cirrhosis or chronic renal insufficiency (serum creatinine > 2 mg/dL).
- •Atrial fibrillation with rapid ventricular response (heart rate > 110 bpm) or ventricular arrhythmia (frequent PVCs, ventricular tachycardia).
- •Acute myocardial infarction within 12 weeks of patient study registration.
- •Known pulmonary embolism.
- •Known or suspected lung cancer.
- •Known neuromuscular disease, stroke with residual hemiparesis, or untreated Parkinsonism
- •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or sub dermal implants).
- •Inability to understand instructions.
- •Participation in another investigational drug clinical trial within 30 days of patient study registration.
研究组 & 干预措施
Formoterol via DPI then Formoterol via nebulizer
Group A: Received Formoterol 12 µg via DPI and placebo via nebulizer at treatment visit #1, and Formoterol 20 µg (solution form) via nebulizer and placebo via DPI at treatment visit 2.
Placebo: The placebo used will be sterile, preservative free, normal saline for nebulizer inhalation and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2.
干预措施: Formoterol (Drug)
Formoterol via DPI then Formoterol via nebulizer
Group A: Received Formoterol 12 µg via DPI and placebo via nebulizer at treatment visit #1, and Formoterol 20 µg (solution form) via nebulizer and placebo via DPI at treatment visit 2.
Placebo: The placebo used will be sterile, preservative free, normal saline for nebulizer inhalation and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2.
干预措施: Placebo (Other)
Formoterol via nebulizer then Formoterol via DPI
Group B: Received Formoterol 20 µg (solution form) via nebulizer and placebo via a DPI at treatment visit #1, and Formoterol 12 µg via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: The placebo used will be sterile, preservative free, normal saline for nebulizer inhalation and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2.
干预措施: Formoterol (Drug)
Formoterol via nebulizer then Formoterol via DPI
Group B: Received Formoterol 20 µg (solution form) via nebulizer and placebo via a DPI at treatment visit #1, and Formoterol 12 µg via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: The placebo used will be sterile, preservative free, normal saline for nebulizer inhalation and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2.
干预措施: Placebo (Other)
结局指标
主要结局
The Difference Between the Values of Area Under the Response Curve for FEV1
时间窗: Baseline through study completion (visit 1 through visit 2)
The difference between the values of area under the response curve for FEV1 from baseline through four hours (AUC FEV1 0-4h) after inhalation of formoterol with a nebulizer or a dry powder inhaler.
次要结局
- Percentage Change in Peak FEV1 From Baseline After Inhalation of Formoterol(From pre-dose formoterol (baseline 0hrs) to 30 minutes, 1,2, and 4 hours post dose at visit 1 and measured again at visit 2)
- Absolute Increase in FEV1 From Baseline After Inhalation of Formoterol(Measured at visit 1 and visit 2 after dosing and all FEV1 testing has been completed)
- Peak FEV1 Between the Two Devices (Nebulizer and DPI)(Measured from Start of visit 1 until the completion of visit 2)
- Change in FEV1 as a Percentage of Predicted Normal After Inhalation of Formoterol(Baseline through study completion (visit 1 through visit 2))
- Area Under the Response Curve for FVC From Baseline Through Four Hours (AUC FVC0-4h) After Inhalation of Formoterol(Measured at visit 1 and again at the end of visit 2)
- Percentage Change in Peak FVC From Baseline After Inhalation of Formoterol(Measured at visit 1 and again at the end of visit 2)
- Peak FVC Between the Two Devices (Nebulizer and DPI)(Peak FVC at visit 1 will be compared to the peak FVC at visit 2 for any significant change.)
- Change in Dyspnea Based on the Borg Dyspnea Scale for Shortness of Breath (Pre-dose Administration and 60 Minutes After Inhalation of Formoterol With a Nebulizer or a DPI)(Measured at visit 1 and again at the end of visit 2)
研究者
Rajiv Dhand, MD
Principal Investigator
University of Tennessee Graduate School of Medicine