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This randomized, single-dose, double-blind, double-dummy, four-period, four-sequence, four-treatment, placebo and active controlled, comparative, multiple-center, crossover-design bronchoprovocation study has been designed to evaluate the pharmacodynamic equivalence of albuterol sulfate HFA inhalation aerosol, eq 90 mcg base (Amneal Ireland Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in patients with stable mild asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Product | Placebo Comparator | One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols |
|
| 90 mcg Reference Product | Active Comparator | One actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols |
|
| 180 mcg Reference Product | Active Comparator | One actuation each from two different Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols |
|
| 90 mcg Test Product | Experimental | One actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo Product |
| |
| 90 mcg Reference Product |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Pharmacodynamic Endpoint Post-dose PC20 | Provocative concentration of the methacholine challenge agent required to reduce the FEV1 by 20% following administration of differing doses of albuterol or placebo by inhalation. The 20% reduction in FEV1 will be determined relative to the post-saline FEV1 measure before the placebo or albuterol administration. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irshad Haque | Contact | 631-952-0214 | ihaque@amneal.com |
| Name | Affiliation | Role |
|---|---|---|
| Irshad Haque | Amneal Pharmaceuticals, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amneal Pharmaceuticals LLC | Recruiting | Brookhaven | New York | 11719 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Drug |
90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC] |
|
|
| 180 mcg Reference Product | Drug | 180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC] |
|
|
| 90 mcg Test Product | Drug | 90 mcg Test Product - ALBUTEROL SULFATE HFA [AMNEAL IRELAND LIMITED] |
|
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |