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This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy, adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to Screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1 | Experimental | A006 albuterol inhalation powder, 120 mcg/inhalation, 1 inhalation |
|
| T2 | Experimental | A006 albuterol inhalation powder 180 mcg/ inhalation, 1 inhalation |
|
| T3 | Experimental | A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations |
|
| T4 | Experimental | A006 albuterol inhalation powder 180 mcg/inhalation, 2 inhalations |
|
| P | Placebo Comparator | Placebo, 2 inhalations |
|
| R1 | Active Comparator | Proventil 90 mcg/inhalation, 2 inhalations |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albuterol inhalation powder | Drug | A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Area under the curve (AUC) of post-dose FEV1 percentage changes from the Pre-dose Baseline. The primary analysis of the primary endpoint is to compare the AUC0-t of FEV1, between the A006 treatments and the Placebo Control. | 5, 20, 40, 60, 90; 120, 180, 240, and 360 minutes post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Effect | Time to onset of bronchodilator effect | 0 to 360 minutes |
| Peak Response | peak bronchodilator response | 0 - 360 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Safety Monitor | Amphastar Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amphastar Site 0001 | San Jose | California | 95117 | United States | ||
| Amphastar Site 0007 |
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| R2 | Active Comparator | Proventil 90 mcg/inhalation, 4 inhalations |
|
| albuterol inhalation powder | Drug | A006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation |
|
| albuterol inhalation powder | Drug | A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations |
|
| albuterol inhalation powder | Drug | A006 albuterol inhalation powder, 180 mcg/inhalation, 2 inhalations |
|
| Placebo | Drug | placebo, lactose inhalation carrier |
|
| albuterol inhalation aerosol | Drug | albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations |
|
|
| albuterol inhalation aerosol | Drug | albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations |
|
|
| Duration | Duration of effect | 0 - 360 minutes |
| Response Rate | Bronchodilatory Response Rate | 0 - 360 minutes |
| Hand Tremor | Evaluation of hand tremor | within 5 min. prior to dosing and 50 and 360 min post-dose. |
| Vital Signs | Pulse, heartrate, respirations, blood pressure | within 15 min. prior to dosing, and 30, 90 and 360 min post-dose. |
| 12 lead ECG | 12-lead ECG for routine and QT/QTc evaluations | within 15 min. prior to dosing and at 50 and 360 min postdose. |
| Blood Work | Collect blood samples (~5 mL) for serum glucose and K+ tests | within 15 min. prior to dosing, and 30 and 120 min. postdose |
| Centennial |
| Colorado |
| 80112 |
| United States |
| Amphastar Site 0008 | Denver | Colorado | 80230 | United States |
| Amphastar Site 0039 | Lakewood | Colorado | 80401 | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001986 | Bronchial Spasm |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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