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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01641081 | Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma | PHASE2 | COMPLETED | 174 | — | — | Jun 1, 2012 | Feb 1, 2013 | Feb 28, 2017 | 29 | United States |
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
| Arm | Type | Description |
|---|---|---|
| Experimental 1 | EXPERIMENTAL | Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose |
| Experimental 2 | EXPERIMENTAL | Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose |
| Active Comparator 1 | ACTIVE_COMPARATOR | Foradil Aerolizer, Low Dose |
| Active Comparator 2 | ACTIVE_COMPARATOR | Foradil Aerolizer, High Dose |
| Placebo | PLACEBO_COMPARATOR | Dose matched placebo |
| Name | Type | Description |
|---|---|---|
| Formoterol Fumarate in the Pressair DPI, Low Dose | DRUG | Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days |
| Formoterol Fumarate in the Pressair DPI, High Dose | DRUG | Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days |
| Foradil Aerolizer, Low Dose | DRUG | Foradil Aerolizer 12 micrograms, twice a day for 14 days |
| Foradil Aerolizer, High Dose | DRUG | Foradil Aerolizer 24 micrograms, twice per day for 14 days |
| Placebo | DRUG | Placebo in the Pressair for 14 days |
Inclusions: * Patients with mild-to-moderate asthma for at least 6 months prior to Visit 1 (as defined in the GINA Guidelines) which is unlikely to exacerbate during the study (e.g., due to seasonal allergen exposure). * Patients must be on a stable dose of Inhaled Corticosteroids (ICS) for at leas...