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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01591044 | A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma | PHASE2 | COMPLETED | 301 | — | — | Jul 1, 2012 | Jul 1, 2013 | Sep 29, 2016 | 59 | United States, Canada |
Change from baseline in pre-BD FEV1 (% predicted) at Week 8.
| Arm | Type | Description |
|---|---|---|
| R940343 2mg, 2 puffs bid | ACTIVE_COMPARATOR | R343 2mg, 2 puffs bid |
| Placebo | PLACEBO_COMPARATOR | - |
| R940343 1mg, 1 puff bid | ACTIVE_COMPARATOR | R343 1mg, 1 puff bid |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | 1 puff bid or 2 puffs bid |
| R940343 1mg | DRUG | R343 1mg, 1 puff bid |
| R940343 2mg | DRUG | R343 2mg, 2 puffs bid |
Inclusion Criteria: * Clinical history of asthma * Ability to perform spirometry Exclusion Criteria: * Chronic obstructive pulmonary disease or bronchiectasis * Upper or lower respiratory infection