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| Name | Class |
|---|---|
| Becro Ltd. | INDUSTRY |
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Τherapeutic equivalence, randomized, multiple-dose, placebo-controlled, observer-blind, parallel group design consisting of a 2-week run-in period followed by a 4-week treatment period with Fluticasone propionate 100 mcg/ blister oral inhalation powder/Respirent Pharmaceuticals (Test) or FLOVENT DISKUS® 100mcg blister oral inhalation powder (Reference) or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental | Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticals |
|
| Reference Product | Active Comparator | FLOVENT DISKUSĀ® 100 mcg/blister oral inhalation powder/GSK |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticals | Drug | twice daily inhalation throughout the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-dose FEV1 | FEV1 measured in the morning prior to the dosing of inhaled medications on the last day of a 28-days treatment after adjustment for baseline | 28-days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konstantinos Kostikas, Associate Professor | University of Ioannina Department of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BECRO Ltd. | Athens | Greece |
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Observer-blind
| FLOVENT DISKUSĀ® 100 mcg/blister oral inhalation powder/GSK | Drug | twice daily inhalation throughout the study |
|
|
| Placebo | Drug | twice daily inhalation throughout the study |
|
| ID | Term |
|---|---|
| D001249 | Asthma |
| 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 |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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