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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00623714 | Induced Sputum Study (0000-065) | PHASE1 | COMPLETED | 13 | — | — | Jan 1, 2008 | Mar 1, 2009 | May 5, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | study medication + Pbo |
| Arm 2 | EXPERIMENTAL | Pbo + study medication |
| Name | Type | Description |
|---|---|---|
| Comparator: fluticasone | DRUG | Two puffs, of 250 µg each, will be administered to each patient to obtain a 500-µg dose at each prespecified time point. A total of five (5) doses (500 µg) each of inhaled fluticasone will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day. |
| Placebo | DRUG | Two puffs, of placebo, will be administered to each patient at each prespecified time point. A total of five (5) doses of placebo will be administered during the single blind run-in phase. and matching placebo will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day. |
Inclusion Criteria: * Patient has a history of mild to moderate persistent allergic asthma for at least 6 months with typical symptoms, including cough, wheezing, and shortness of breath, is clinically stable and has no history of recent respiratory tract infection within 3 weeks of the start of th...