COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers
- Registration Number
- NCT02291016
- Lead Sponsor
- University of Tennessee Graduate School of Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Formoterol via DPI then Formoterol via nebulizer Placebo 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. Formoterol via nebulizer then Formoterol via DPI Placebo 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. Formoterol via DPI then Formoterol via nebulizer Formoterol 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. Formoterol via nebulizer then Formoterol via DPI Formoterol 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.
- Primary Outcome Measures
Name Time Method The Difference Between the Values of Area Under the Response Curve for FEV1 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.
- Secondary Outcome Measures
Name Time Method 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 Change in peak FEV1 from Baseline. This will be completed at visit 1 and visit 2.
Steps:
1. A baseline (pre-dose formoterol) FEV1 will be recorded.
2. Subjects will be dosed with formoterol.
3. Serial FEV1 assessments will completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol so a peak measurement can be recorded.
4. A percentage of change between the baseline and peak FEV1 will be recorded for this outcome measure. A higher value indicates a better result.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 Increase in FEV1 from Baseline to 4 hours post dose of formoterol. This will be completed at visit 1 and visit 2.
Steps:
1. A baseline (pre-dose formoterol) FEV1 was recorded.
2. Subjects was dosed with formoterol.
3. Serial FEV1 assessments were completed, and recorded at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol so serial FEV1 measurements could be recorded.Peak FEV1 Between the Two Devices (Nebulizer and DPI) Measured from Start of visit 1 until the completion of visit 2 Change in peak FEV1 from Baseline. This will be completed at visit 1 and visit 2.
Steps:
1. A baseline (pre-dose formoterol) FEV1 was recorded.
2. Subjects were dosed with formoterol.
3. Serial FEV1 assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol so a peak measurement could recorded.
5. Peak measurements from visit 1 and visit 2 will be compared for any significant change in FEV1 values.Change in FEV1 as a Percentage of Predicted Normal After Inhalation of Formoterol Baseline through study completion (visit 1 through visit 2) Change in FEV1 from Baseline through 4 hours post formoterol dose. This was completed at visit 1 and visit 2.
Steps:
1. A baseline (pre-dose formoterol) FEV1 was recorded.
2. Subjects were dosed with formoterol.
3. Serial FEV1 assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol and serial FEV1 values were recorded.
4. A percentage of change from baseline FEV1 to each serial measurement of FEV1 was collected. The % of change at each time point was then used to get a measure of overall percentage change of the predicted FEV1 value.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 Steps:
1. A baseline (pre-dose formoterol) FVC was recorded.
2. Subjects were dosed with formoterol.
3. Serial FVC assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol and serial FVC values were recorded.
Data was all time points were used to obtain the total area under the curvePercentage Change in Peak FVC From Baseline After Inhalation of Formoterol Measured at visit 1 and again at the end of visit 2 1. A baseline (pre-dose formoterol) FVC was recorded.
2. Subjects were dosed with formoterol.
3. Serial FVC assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol and serial FVC values were recorded.
4. A percentage of change between the baseline and peak FVC will be recorded for this outcome measure.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. Steps:
1. A baseline (pre-dose formoterol) FVC was recorded.
2. Subjects were dosed with formoterol.
3. Serial FVC assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol and serial FVC values were recorded.
4. Peak FVC was recorded for this outcome measure and compared amongst groups.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 The Shortness of Breath Modified Borg Dyspnea Scale The scale goes from 0-10, zero meaning no difficulty breathing and ten meaning maximal difficulty. A decrease of score indicates an improvement. Patients were asked to complete the scale pre-dose and again one hour post formoterol dose. This was completed at both visit 1 and visit 2. The value recorded was the difference between the baseline value and the post 60 minute value.
Trial Locations
- Locations (1)
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States