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This study is evaluating the effectiveness of a dose counter for an inhaler device used to deliver medication to people diagnosed with asthma or COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albuterol MDI | All participants in this study will receive an albuterol MDI inhaler. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol | Drug | Albuterol MDI with integrated dose counter. Each participant will use 2 oral inhalations of 90 micrograms each of albuterol twice a day for the length of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of times the counter advanced but the inhaler did not actuate | MDI actuates but the counter display does not advance. | Days 1 through 46 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of times the inhaler actuated but the counter did not advance. | Counter advances but the MDI does not actuate. | Days 1 through 46 |
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Inclusion Criteria:
Exclusion Criteria:
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People diagnosed with asthma or Chronic Obstructive Pulmonary Disease (also known as COPD, emphysema or chronic bronchitis)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Project Leader | Teva Respiratory R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Clinical Study Site | Glendale | Arizona | United States | |||
| Teva Clinical Study Site 10100 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23265285 | Derived | Given J, Taveras H, Iverson H, Lepore M. Prospective, open-label assessment of albuterol sulfate hydrofluoroalkane metered-dose inhaler with new integrated dose counter. Allergy Asthma Proc. 2013 Jan-Feb;34(1):42-51. doi: 10.2500/aap.2012.33.3647. Epub 2012 Dec 20. |
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| Mission Viejo |
| California |
| United States |
| Teva Clinical Study Site 10093 | Orange | California | United States |
| Teva Clinical Study Site 10089 | San Diego | California | United States |
| Teva Clinical Study Site 10098 | Wheat Ridge | Colorado | United States |
| Teva Clinical Study Site | Miami | Florida | United States |
| Teva Clinical Study Site 10082 | Ormond Beach | Florida | United States |
| Teva Clinical Study Site | Tamarac | Florida | United States |
| Teva Clinical Study Site 10090 | Indianapolis | Indiana | United States |
| Teva Clinical Study Site 10097 | Overland Park | Kansas | United States |
| Teva Clinical Study Site 10087 | Wichita | Kansas | United States |
| Teva Clinical Study Site | Fall River | Massachusetts | United States |
| Teva Clinical Study Site 10094 | North Dartmouth | Massachusetts | United States |
| Teva Clinical Study Site 10086 | Minneapolis | Minnesota | United States |
| Teva Clinical Study Site 10083 | High Point | North Carolina | United States |
| Teva Clinical Study Site 10092 | Raleigh | North Carolina | United States |
| Teva Clinical Study Site 10085 | Canton | Ohio | United States |
| Teva Clinical Study Site 10080 | Tulsa | Oklahoma | United States |
| Teva Clinical Study Site 10088 | Eugene | Oregon | United States |
| Teva Clinical Study Site 10095 | Portland | Oregon | United States |
| Teva Clinical Study Site 10081 | Greenville | South Carolina | United States |
| Teva Clinical Study Site 10084 | Spartanburg | South Carolina | United States |
| Teva Clinical Study Site | Dallas | Texas | United States |
| Teva Clinical Study Site 10091 | New Braunfels | Texas | United States |
| Teva Clinical Study Site 10099 | Seattle | Washington | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| D029481 | Bronchitis, Chronic |
| 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 |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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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