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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
7
Comparison of dosage administered via a nebulizer versus dosage administered via a dry powder inhaler. 12 µg Formoterol with the dry powder inhaler and 20 µg (solution form) of Formoterol with the nebulizer. Patients will receive formoterol and placebo at both study visit #1 and visit #2.
Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer 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.
University of Tennessee Medical Center
Knoxville, Tennessee, United States
The Difference Between the Values of Area Under the Response Curve for FEV1
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.
Time frame: Baseline through study completion (visit 1 through visit 2)
Percentage Change in Peak FEV1 From Baseline After Inhalation of Formoterol
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.
Time frame: 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
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.
Time frame: 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)
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.
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Time frame: 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
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.
Time frame: 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
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 curve
Time frame: Measured at visit 1 and again at the end of visit 2
Percentage Change in Peak FVC From Baseline After Inhalation of Formoterol
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.
Time frame: Measured at visit 1 and again at the end of visit 2
Peak FVC Between the Two Devices (Nebulizer and DPI)
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.
Time frame: 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)
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.
Time frame: Measured at visit 1 and again at the end of visit 2