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The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
| |
| 4 | Active Comparator |
| |
| 5 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone propionate/formoterol fumarate | Drug | inhalation suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma AUC(0-t) after 1 week of dosing | PK sampling over 24 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 | pre-dose and 2 hrs post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | San Diego | California | 92120 | United States | ||
| Investigative Site |
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| fluticasone propionate |
| Drug |
inhalation suspension |
|
| formoterol fumarate | Drug | inhalation solution |
|
| Panama City |
| Florida |
| 32405 |
| United States |
| Investigative Site | Madisonville | Kentucky | 42431 | United States |
| Investigative Site | Sunset | Louisiana | 70584 | United States |
| Investigative Site | Charlotte | North Carolina | 28207 | United States |
| Investigative Site | Medford | Oregon | 97504 | United States |
| Investigative Site | Greenville | South Carolina | 29615 | United States |
| Investigative Site | Spartanburg | South Carolina | 29303 | United States |
| Investigative Site | Union | South Carolina | 29379 | United States |
| Investigative Site | San Antonio | Texas | 78205 | United States |
| Investigative Site | Spokane | Washington | 99207 | United States |
| Investigative Site | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D004194 | Disease |
| 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 |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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