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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04882124 | Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD | PHASE2 | COMPLETED | 38 | — | — | Sep 24, 2021 | Sep 15, 2022 | Nov 28, 2022 | 15 | United States, Australia +4 |
The Evaluating Respiratory Symptoms (E-RS) scale is based on the 11 respiratory symptom items included in the EXACT Tool (a validated 14-item electronic questionnaire). These 11 items generate a total score of 0-40, with higher scores indicating more severe respiratory symptoms.
| Arm | Type | Description |
|---|---|---|
| CSJ117 8mg | EXPERIMENTAL | Intervention: Drug: CSJ117 |
| CSJ117 4mg | EXPERIMENTAL | Intervention: Drug: CSJ117 |
| CSJ117 Placebo | PLACEBO_COMPARATOR | Intervention: Drug: Placebo |
| Name | Type | Description |
|---|---|---|
| CSJ117 | DRUG | CSJ117 (4 mg and 8 mg) inhaled once daily for 12 weeks. Delivered via Concept1 device. |
| Placebo | DRUG | Placebo inhaled once daily for 12 weeks. Delivered via Concept1 device |
Inclusion Criteria: * Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure * Current or ex-smokers who have a smoking history of at least 10 pack years * Patients who have been treated with a triple combination of ...