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| Name | Class |
|---|---|
| Mylan Specialty, LP | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formoterol via DPI then Formoterol via nebulizer | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formoterol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through study completion (visit 1 through visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajiv Dhand, MD | University of Tennessee Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 |
| |||||||||||||
| Visit 2 |
|
Seven total subjects were studied. Order of crossover dosing as follows:
Randomization:
Group A:formoterol via DPI/placebo via nebulizer visit 1, and formoterol via nebulizer/placebo via DPI at visit 2.
Group B:formoterol via nebulizer/placebo via a DPI at visit 1, and formoterol via DPI/placebo via nebulizer at visit 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Mean | Standard Deviation | mcg*hr/mL | Baseline through study completion (visit 1 through visit 2) |
|
Collected from subject randomization through subject study completion (visit 1-visit 2), which was approximately 9 days total.
Instead of reporting the findings from Group A ( Dosed with Nebulizer placebo and DPI formoterol at visit 1, and dosed with nebulizer formoterol and DPI placebo at visit 2), and Group B (Dosed with nebulizer formoterol and DPI placebo at visit 1 , and dosed with nebulizer placebo and DPI formoterol at visit 2), we reported the adverse event groups by the following: Formoterol via Nebulizer and Formoterol via DPI, as patients were given both in this cross-over study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Formoterol With Nebulizer | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Coordinator | University of Tennessee Graduate School of Medicine | 865-305-7975 | jferris@utmck.edu |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
|
| Placebo | Other | 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. |
|
|
| 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:
| 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:
5. Peak measurements from visit 1 and visit 2 will be compared for any significant change in FEV1 values. | 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:
| 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:
Data was all time points were used to obtain the total area under the curve | 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) | Steps:
| 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. | Measured at visit 1 and again at the end of visit 2 |
| NOT COMPLETED |
|
| BG001 | 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: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Formoterol With Dry Powder Inhaler | 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. |
|
|
| Secondary | 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:
| 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. | Posted | Mean | Standard Deviation | percent change | 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 |
|
|
|
| Secondary | 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:
| 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. | Posted | Mean | Standard Deviation | L/sec | Measured at visit 1 and visit 2 after dosing and all FEV1 testing has been completed |
|
|
|
| Secondary | 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:
5. Peak measurements from visit 1 and visit 2 will be compared for any significant change in FEV1 values. | 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. | Posted | Mean | Standard Deviation | L/sec | Measured from Start of visit 1 until the completion of visit 2 |
|
|
|
| Secondary | 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:
| 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. | Posted | Mean | Standard Deviation | percentage change of % predicted FEV1 | Baseline through study completion (visit 1 through visit 2) |
|
|
|
| Secondary | Area Under the Response Curve for FVC From Baseline Through Four Hours (AUC FVC0-4h) After Inhalation of Formoterol | Steps:
Data was all time points were used to obtain the total area under the curve | 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. | Posted | Mean | Standard Deviation | mcg*hr/mL | Measured at visit 1 and again at the end of visit 2 |
|
|
|
| Secondary | Percentage Change in Peak FVC From Baseline After Inhalation of Formoterol |
| Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included. | Posted | Mean | Standard Deviation | percent change | Measured at visit 1 and again at the end of visit 2 |
|
|
|
| Secondary | Peak FVC Between the Two Devices (Nebulizer and DPI) | Steps:
| Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included. | Posted | Mean | Standard Deviation | L/sec | Peak FVC at visit 1 will be compared to the peak FVC at visit 2 for any significant change. |
|
|
|
| Secondary | 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. | Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included. | Posted | Mean | Standard Deviation | change in score | Measured at visit 1 and again at the end of visit 2 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Formoterol With Dry Powder Inhaler | One dose of Formoterol 12 µg (solution form) via DPI 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. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |