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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00442117 | A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880) | PHASE3 | COMPLETED | 180 | — | — | Jun 1, 2007 | Jul 1, 2009 | May 20, 2024 | - | — |
FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.
| Arm | Type | Description |
|---|---|---|
| MF-DPI | EXPERIMENTAL | MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) |
| BUD-DPI | ACTIVE_COMPARATOR | Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) |
| Name | Type | Description |
|---|---|---|
| mometasone furoate dry powder inhaler | DRUG | MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks. |
| Budesonide DPI | DRUG | Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks. |
Inclusion Criteria: * Subjects must be 12 years of age or older of either gender, who (and their parent/guardian if the subject is under the age of 20) must demonstrate their willingness to sign and write informed consent. * Subjects must have had a history of asthma for at least 6 months. * The su...