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| Name | Class |
|---|---|
| Teva Pharmaceuticals USA | INDUSTRY |
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A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects with Asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Test Product | Experimental | Fluticasone propionate pressurized metered dose inhaler, 110 mcg per actuation |
|
| Reference Listed Drug | Active Comparator | Flovent HFA pressurized metered dose inhaler, 110 mcg per actuation |
|
| Placebo | Placebo Comparator | Placebo pressurized metered dose inhaler, no active content |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate pressurized metered dose inhaler | Drug | 110 mcg per actuation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in baseline adjusted morning pre-dose FEV1 from the time of treatment randomization to Week 4. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Superiority over Placebo | To confirm the Test and Reference listed Drug products are statistically superior to placebo (p< 0.05) on the primary study endpoint. | Approximately 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Spartanburg | South Carolina | 29303 | United States |
Participant data will not be shared.
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| Flovent HFA pressurized metered dose inhaler | Drug | 110 mcg per actuation |
|
|
| Placebo pressurized metered dose inhaler | Drug | no active content |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 30, 2023 | Feb 22, 2023 | 7 | ||
| Aug 15, 2024 | Sep 10, 2024 | 8 |
| 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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