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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01868009 | DISKUS vs. ELLIPTA Device Preference Study in Chronic Obstructive Pulmonary Disease (COPD) | PHASE3 | COMPLETED | 287 | — | — | May 1, 2013 | Jul 1, 2013 | Mar 4, 2014 | 17 | United States |
The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the numbers on the dose counter was summarized by study inhaler use sequence.
| Arm | Type | Description |
|---|---|---|
| ELLIPTA Period 1 and DISKUS Period 2 Arm | EXPERIMENTAL | Subjects will use the ELLIPTA inhaler once daily for 5 to 9 days during the first period followed by the DISKUS inhaler twice daily for 5 to 9 days during the second period. |
| DISKUS Period 1 and ELLIPTA Period 2 Arm | EXPERIMENTAL | Subjects will use the DISKUS inhaler twice daily for 5 to 9 days during the first period followed by the ELLIPTA inhaler once daily for 5 to 9 days during the second period. |
| Name | Type | Description |
|---|---|---|
| ELLIPTA | DEVICE | Novel dry powder inhaler (placebo) with 30 doses (2 strips with 30 blisters per strip) |
| DISKUS | DEVICE | Multidose dry powder inhaler (placebo) containing a foil strip worth 60 blisters (1 strip with 60 blisters per strip) |
Inclusion Criteria: * 1\. Informed consent * Subject must give their signed and dated written informed consent to participate. * Subject understands and is willing, able, and likely to comply with study procedures and restrictions. * Subject must be able to read, comprehend, and record information ...