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The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare the preference/compliance of BID nebulization to QID use of MDI
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formoterol Fumurate inhalation solution 20 mcg | Drug | |||
| Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function after 2 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function at each time point, patient questionnaires, medication compliance, | ||
| adverse events, clinical labs, vital signs, ECGs, physical exams |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Diego | California | 92120 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19232039 | Result | Sutherland ER, Brazinsky S, Feldman G, McGinty J, Tomlinson L, Denis-Mize K. Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI. Curr Med Res Opin. 2009 Mar;25(3):653-61. doi: 10.1185/03007990802708152. |
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| Denver |
| Colorado |
| 80206 |
| United States |
| Research Site | Wheat Ridge | Colorado | 80033 | United States |
| Research Site | Panama City | Florida | 32405 | United States |
| Research Site | Pensacola | Florida | 32504 | United States |
| Research Site | Coeur d'Alene | Idaho | 83814 | United States |
| Research Site | Sunset | Louisiana | 70584 | United States |
| Research Site | Charlotte | North Carolina | 28207 | United States |
| Research Site | Portland | Oregon | 97213 | United States |
| Research Site | Gaffney | South Carolina | 29340 | United States |
| Research Site | Spartanburg | South Carolina | 29303 | United States |
| Research Site | Johnson City | Tennessee | 37601 | United States |
| Research Site | San Antonio | Texas | 78205 | United States |
| Research Site | Spokane | Washington | 99204 | United States |
| Research Site | Morgantown | West Virginia | 26505 | United States |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009241 | Ipratropium |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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