Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00370097 | FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects | PHASE1 | COMPLETED | 16 | — | — | Aug 30, 2006 | Apr 12, 2007 | Sep 11, 2017 | 7 | United States |
| Arm | Type | Description |
|---|---|---|
| Subjects receiving HFA | EXPERIMENTAL | Subjects in Session 1 will receive two inhalations of placebo HFA by meter-dose inhaler (MDI) twice daily and in Session 2 subjects will receive two inhalations of fluticasone propionate (FP) HFA MDI 44 mcg twice daily |
| Name | Type | Description |
|---|---|---|
| FLOVENT (fluticasone propionate) HFA | DRUG | FLOVENT HFA consists of a white to off-white suspension of FP (micronized) in a liquefied hydrofluoroalkane propellant, 1,1,1,2-tetrafluoroethane. Subject will receive FP HFA using an Aerochamber Plus with Infant Mask. |
| Placebo HFA | DRUG | Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask. |
Inclusion Criteria: * Subjects who have experienced 2 or more wheezing episodes in the previous 6 months. * Subjects may not have taken any corticosteroids in the 4 weeks prior to dosing * Parents/guardians should be able to read and comprehend diary information collected throughout the study * Par...