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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02474017 | An Open Study to Assess the Robustness of the CRC749 Inhaler | PHASE1 | COMPLETED | 111 | — | — | May 1, 2015 | Jun 1, 2015 | Mar 7, 2022 | 2 | United Kingdom |
| NCT02215122 | Bioequivalence Study to Assess Systemic Exposure of FP and SAL FDC From Different DPIs | PHASE1 | COMPLETED | 40 | — | — | Oct 1, 2013 | Nov 1, 2013 | Mar 7, 2022 | 1 | United States |
CRC749 inhaler robustness will be assessed by in vitro testing of the CRC749 inhaler after 3 weeks of patient use of the MGR001 product.
| Arm | Type | Description |
|---|---|---|
| MGR001 | EXPERIMENTAL | MGR001 (FP/Salmeterol) (250/50 µg) twice daily (BID) |
| Advair® Diskus® | EXPERIMENTAL | FP/SAL 250/50 µg 3 x inhalations (total dose 750/150 µg) administered via Diskus® inhaler. |
| Seretide™ Accuhaler™ | EXPERIMENTAL | FP/SAL 250/50 µg 3 x inhalations (total dose 750/150 µg) administered via Accuhaler™ inhaler. |
| Name | Type | Description |
|---|---|---|
| MGR001 | DRUG | Fluticasone Propionate / Salmeterol administered using CRC749 inhaler |
| CRC749 inhaler | DEVICE | - |
| Advair® Diskus® | DRUG | Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA) |
| Seretide™ Accuhaler™ | DRUG | Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA) |
Inclusion Criteria: 1. Males and females at least 12 years of age. 2. A clinical diagnosis for at least 12 weeks prior to screening of asthma or COPD and stable treatment. 3. Spirometry following salbutamol showing FEV1 ≥40% of predicted normal and FEV1/FVC ratio \<0.7 for COPD subjects. 4. Spirome...