Trial Outcomes & Findings for COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers (NCT NCT02291016)
NCT ID: NCT02291016
Last Updated: 2019-03-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Baseline through study completion (visit 1 through visit 2)
Results posted on
2019-03-19
Participant Flow
Participant milestones
| Measure |
Formoterol Via DPI Then Formoterol Via Nebulizer
Group A: Received Formoterol 12 µg via DPI and placebo via nebulizer at treatment visit #1, and then Formoterol 20 µg (solution form) via nebulizer and placebo via DPI at treatment visit 2.
Placebo: 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.
|
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 then Formoterol 12 µg via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
|---|---|---|
|
Visit 1
STARTED
|
2
|
5
|
|
Visit 1
COMPLETED
|
2
|
5
|
|
Visit 1
NOT COMPLETED
|
0
|
0
|
|
Visit 2
STARTED
|
2
|
5
|
|
Visit 2
COMPLETED
|
1
|
5
|
|
Visit 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers
Baseline characteristics by cohort
| Measure |
Formoterol Via DPI Then Formoterol Via Nebulizer
n=2 Participants
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: 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.
|
Formoterol Via Nebulizer Then Formoterol Via DPI
n=5 Participants
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: 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.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through study completion (visit 1 through visit 2)Population: Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included. One patient did not complete the full study, which is why only 6 participants who took formoterol with Nebulizer were analyzed. Collected at baseline, visit 1, and visit 2 at pre-dose then 30 minutes,1hr, 2hr, and 4hr post-dose
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.
Outcome measures
| Measure |
Formoterol With Nebilizer and Placebo With DPI
n=6 Participants
One dose of Formoterol 20 µg (solution form) via nebulizer at either visit 1 or visit 2 depending on group randomization, which is listed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
Formoterol With Dry Powder Inhaler
n=7 Participants
Formoterol: One dosing of 12 µg via dry powder inhaler at either visit 1 or visit 2 depending on randomization assignment, which is detailed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
|---|---|---|
|
The Difference Between the Values of Area Under the Response Curve for FEV1
|
203.0 mcg*hr/mL
Standard Deviation 77.2
|
185.0 mcg*hr/mL
Standard Deviation 84.0
|
SECONDARY outcome
Timeframe: From pre-dose formoterol (baseline 0hrs) to 30 minutes, 1,2, and 4 hours post dose at visit 1 and measured again at visit 2Population: Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included. One patient did not complete the full study, which is why only 6 participants who took formoterol with Nebulizer were analyzed.
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.
Outcome measures
| Measure |
Formoterol With Nebilizer and Placebo With DPI
n=6 Participants
One dose of Formoterol 20 µg (solution form) via nebulizer at either visit 1 or visit 2 depending on group randomization, which is listed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
Formoterol With Dry Powder Inhaler
n=7 Participants
Formoterol: One dosing of 12 µg via dry powder inhaler at either visit 1 or visit 2 depending on randomization assignment, which is detailed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
|---|---|---|
|
Percentage Change in Peak FEV1 From Baseline After Inhalation of Formoterol
|
28.2 percent change
Standard Deviation 12.3
|
21.1 percent change
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: Measured at visit 1 and visit 2 after dosing and all FEV1 testing has been completedPopulation: Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included.One patient did not complete the full study, which is why only 6 participants who took formoterol with Nebulizer were analyzed.
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.
Outcome measures
| Measure |
Formoterol With Nebilizer and Placebo With DPI
n=6 Participants
One dose of Formoterol 20 µg (solution form) via nebulizer at either visit 1 or visit 2 depending on group randomization, which is listed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
Formoterol With Dry Powder Inhaler
n=7 Participants
Formoterol: One dosing of 12 µg via dry powder inhaler at either visit 1 or visit 2 depending on randomization assignment, which is detailed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
|---|---|---|
|
Absolute Increase in FEV1 From Baseline After Inhalation of Formoterol
|
12.2 L/sec
Standard Deviation 7.1
|
9.5 L/sec
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Measured from Start of visit 1 until the completion of visit 2Population: Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included. One patient did not complete the full study, which is why only 6 participants who took formoterol with Nebulizer were analyzed.
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.
Outcome measures
| Measure |
Formoterol With Nebilizer and Placebo With DPI
n=6 Participants
One dose of Formoterol 20 µg (solution form) via nebulizer at either visit 1 or visit 2 depending on group randomization, which is listed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
Formoterol With Dry Powder Inhaler
n=7 Participants
Formoterol: One dosing of 12 µg via dry powder inhaler at either visit 1 or visit 2 depending on randomization assignment, which is detailed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
|---|---|---|
|
Peak FEV1 Between the Two Devices (Nebulizer and DPI)
|
12.2 L/sec
Standard Deviation 7.1
|
9.5 L/sec
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Baseline through study completion (visit 1 through visit 2)Population: Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included. One patient did not complete the full study, which is why only 6 participants who took formoterol with Nebulizer were analyzed.
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.
Outcome measures
| Measure |
Formoterol With Nebilizer and Placebo With DPI
n=6 Participants
One dose of Formoterol 20 µg (solution form) via nebulizer at either visit 1 or visit 2 depending on group randomization, which is listed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
Formoterol With Dry Powder Inhaler
n=7 Participants
Formoterol: One dosing of 12 µg via dry powder inhaler at either visit 1 or visit 2 depending on randomization assignment, which is detailed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
|---|---|---|
|
Change in FEV1 as a Percentage of Predicted Normal After Inhalation of Formoterol
|
21.5 percentage change of % predicted FEV1
Standard Deviation 11.8
|
18.4 percentage change of % predicted FEV1
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: Measured at visit 1 and again at the end of visit 2Population: Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included.One patient did not complete the full study, which is why only 6 participants who took formoterol with nebulizer were analyzed.
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
Outcome measures
| Measure |
Formoterol With Nebilizer and Placebo With DPI
n=6 Participants
One dose of Formoterol 20 µg (solution form) via nebulizer at either visit 1 or visit 2 depending on group randomization, which is listed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
Formoterol With Dry Powder Inhaler
n=7 Participants
Formoterol: One dosing of 12 µg via dry powder inhaler at either visit 1 or visit 2 depending on randomization assignment, which is detailed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
|---|---|---|
|
Area Under the Response Curve for FVC From Baseline Through Four Hours (AUC FVC0-4h) After Inhalation of Formoterol
|
327.0 mcg*hr/mL
Standard Deviation 75.0
|
293.4 mcg*hr/mL
Standard Deviation 49.8
|
SECONDARY outcome
Timeframe: Measured at visit 1 and again at the end of visit 2Population: Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included.
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.
Outcome measures
| Measure |
Formoterol With Nebilizer and Placebo With DPI
n=6 Participants
One dose of Formoterol 20 µg (solution form) via nebulizer at either visit 1 or visit 2 depending on group randomization, which is listed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
Formoterol With Dry Powder Inhaler
n=7 Participants
Formoterol: One dosing of 12 µg via dry powder inhaler at either visit 1 or visit 2 depending on randomization assignment, which is detailed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
|---|---|---|
|
Percentage Change in Peak FVC From Baseline After Inhalation of Formoterol
|
22.1 percent change
Standard Deviation 11.7
|
18.2 percent change
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: Peak FVC at visit 1 will be compared to the peak FVC at visit 2 for any significant change.Population: Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included.
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.
Outcome measures
| Measure |
Formoterol With Nebilizer and Placebo With DPI
n=6 Participants
One dose of Formoterol 20 µg (solution form) via nebulizer at either visit 1 or visit 2 depending on group randomization, which is listed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
Formoterol With Dry Powder Inhaler
n=7 Participants
Formoterol: One dosing of 12 µg via dry powder inhaler at either visit 1 or visit 2 depending on randomization assignment, which is detailed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
|---|---|---|
|
Peak FVC Between the Two Devices (Nebulizer and DPI)
|
86.7 L/sec
Standard Deviation 22.0
|
82.0 L/sec
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Measured at visit 1 and again at the end of visit 2Population: Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included.
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.
Outcome measures
| Measure |
Formoterol With Nebilizer and Placebo With DPI
n=6 Participants
One dose of Formoterol 20 µg (solution form) via nebulizer at either visit 1 or visit 2 depending on group randomization, which is listed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
|
Formoterol With Dry Powder Inhaler
n=7 Participants
Formoterol: One dosing of 12 µg via dry powder inhaler at either visit 1 or visit 2 depending on randomization assignment, which is detailed below.
Randomization:
Group A: Received formoterol via DPI and placebo via nebulizer at treatment visit #1, and formoterol via nebulizer and placebo via DPI at treatment visit 2.
Group B: Received formoterol via nebulizer and placebo via a DPI at treatment visit #1, and formoterol via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: 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.
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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)
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-0.59 change in score
Standard Deviation 0.63
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0 change in score
Standard Deviation .50
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Adverse Events
Formoterol With Nebulizer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Formoterol With Dry Powder Inhaler
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Trials Coordinator
University of Tennessee Graduate School of Medicine
Phone: 865-305-7975
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place