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The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PT005 MDI (Dose 1) | Experimental | PT005 MDI (Dose 1) |
|
| PT005 MDI (Dose 2) | Experimental | PT005 MDI (Dose 2) |
|
| PT005 MDI (Dose 3) | Experimental | PT005 MDI (Dose 3) |
|
| Placebo MDI | Placebo Comparator | Placebo MDI |
|
| Formoterol Fumarate 12 μg (Foradil® Aerolizer®) | Active Comparator | Formoterol fumarate inhalation powder 12 μg |
|
| Formoterol Fumarate 24 μg (Foradil® Aerolizer®) | Active Comparator | Formoterol fumarate inhalation powder 24 μg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PT005 MDI | Drug | PT005 MDI taken as two inhalations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 AUC0-12 from test day baseline across the three doses of inhaled PT005 compared with placebo | The primary objective of this study is to demonstrate efficacy relative to placebo of PT005 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this study. To this end, each dose of PT005 MDI will be compared to placebo with respect to the primary efficacy endpoint, the change in FEV1 AUC0-12 from baseline. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the dose-response curve of PT005 MDI | The secondary objective of the study is to characterize the dose-response curve of PT005 MDI, to conduct a non-inferiority assessment comparing PT005 MDI within the range of doses evaluated in this study to open-label Foradil Aerolizer 12 µg, and to select the most appropriate dose of PT005 MDI to carry forward into Phase III clinical studies | 1 Day |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other inclusion/exclusion criteria as defined by the protocol
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pearl Investigative Site | Clearwater | Florida | United States | |||
| Pearl Investigative Site |
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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 |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Formoterol Fumarate 12 μg (Foradil® Aerolizer®) | Drug | Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece |
|
|
| Formoterol Fumarate 24 μg (Foradil® Aerolizer®) | Drug | Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece |
|
|
| Placebo MDI | Other | Matching placebo to PT005 MDI taken as two inhalations |
|
| Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events | 1 Day |
| Tampa |
| Florida |
| United States |
| Pearl Investigative Site | Spartanburg | South Carolina | United States |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |