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This is a study to investigate the reliability, ruggedness and safety of the top mounted actuation indicator (TMAI) when used with Levalbuterol HFA MDI.
This is an open-label, multicenter, TMAI study with Levalbuterol HFA MDI in adult and pediatric subjects with asthma or COPD. Period I: One week, open-label, run-in period during which subjects must have asthma or COPD symptoms requiring use of, as needed, Levalbuterol HFA MDI(without TMAI) on at least half of the days [4-12 actuations on a single day]. Period II: Nine week, open-label period during which subjects will use the Levalbuterol HFA MDI with TMAI PRN. The total study duration for a subject will not exceed 10 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Levalbuterol HFA MDI with top mounted actuation indicator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levalbuterol HFA MDI with top mounted actuation indicator | Drug | Levalbuterol HFA MDA with top mounted actuation indicator |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI. | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Hanrahan, M.D. | Sumitomo Pharma America, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Encinatas | California | 92024 | United States | |||
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| Label | URL |
|---|---|
| Patient's Instructions for Use | View source |
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| Huntington Beach |
| California |
| 92647 |
| United States |
| Mesa | California | 92626 | United States |
| Orange County | California | 92868 | United States |
| Riverside | California | 92506 | United States |
| San Diego | California | 92120 | United States |
| San Jose | California | 95128 | United States |
| Viejo | California | 92691 | United States |
| Walnut Creek | California | 94596 | United States |
| Tamarac | Florida | 33321 | United States |
| Russells Mills | Massachusetts | 02747 | United States |
| Commack | New York | 11725 | United States |
| Rochester | New York | 14618 | United States |
| Elizabeth City | North Carolina | 27909 | United States |
| Oklahoma City | Oklahoma | 73120 | United States |
| Medford | Oregon | 97504 | United States |
| Portland | Oregon | 97213 | United States |
| Philadelphia | Pennsylvania | 19115 | United States |
| Simpsonville | South Carolina | 29681 | United States |
| Chattanooga | Tennessee | 37421 | United States |
| Austin | Texas | 78750 | United States |
| Braunfels | Texas | 78130 | United States |
| San Antonio | Texas | 78229 | United States |
| Burke | Virginia | 22015 | United States |
| Richmond | Virginia | 23225 | United States |
| Morgantown | West Virginia | 26505 | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| 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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