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To compare the systemic exposure of a single dose of 400 µg of OPTINOSE FLUTICASONE with 440 µg of Flovent® HFA (fluticasone propionate) Inhalation Aerosol in asthmatic subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flovent® HFA 440µg | Active Comparator | Flovent® HFA (fluticasone propionate) Inhalation Aerosol 440 µg |
|
| OPTINOSE™ FLUTICASONE 400µg intranasal | Experimental | OPTINOSE™ FLUTICASONE, single dose of 400 µg intranasally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flovent HFA | Drug |
| ||
| OPTINOSE™ FLUTICASONE |
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of least-squares means of the ln transformed PK parameter AUC0-∞ is the primary endpoint. | Part 2 | Pre-dose and at 0.167, 0.333, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 9, 12, 16, 24, and 36 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian J Stewart, BM, MRCGP, MFPM | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Belfast | BT9 6AD | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31732149 | Derived | Messina JC, Offman E, Carothers JL, Mahmoud RA. A Randomized Comparison of the Pharmacokinetics and Bioavailability of Fluticasone Propionate Delivered via Xhance Exhalation Delivery System Versus Flonase Nasal Spray and Flovent HFA Inhalational Aerosol. Clin Ther. 2019 Nov;41(11):2343-2356. doi: 10.1016/j.clinthera.2019.09.013. Epub 2019 Nov 12. |
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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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