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The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in adult patients with asthma.
This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points in adult patients with asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Fluticasone propionate/salmeterol 100/50 µg |
|
| Comparator | Active Comparator | Fluticasone propionate/salmeterol 100/50 µg |
|
| Placebo | Other | Test Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate/salmeterol 100/50 µg | Drug | Test Arm: Dry powder inhaler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) | Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the treatment | one day |
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Inclusion Criteria
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined Research Orlando | Orlando | Florida | 32807 | 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 |
|---|---|
| D000068298 | Fluticasone |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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A multicenter, randomized, parallel-group, placebo-controlled
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| Placebo |
| Other |
Placebo |
|
| Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT | Drug | Comparator Arm: Dry powder inhaler |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |