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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00686335 | A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma | PHASE2 | COMPLETED | 12 | — | — | Jun 1, 2008 | May 1, 2010 | Dec 17, 2024 | 1 | France |
Variation in the total number of nocturnal awakenings during the last 2 weeks of run-in treatment with Cortancyl and the last 2 weeks of treatment with Lodotra.
| Arm | Type | Description |
|---|---|---|
| Lodotra | EXPERIMENTAL | After the 4 week run-in period with immediate release prednisone (Cortancyl), patients were switched to the identical dose of modified release prednisone tablets (Lodotra). Study medication for the Lodotra treatment period consisted of Lodotra in 2 dose strengths (5 mg and 1 mg prednisone per tablet). Patients were to take their tablets with or after the evening meal (at 10 pm +/- 30 minutes) for 4 weeks. |
| Cortancyl | ACTIVE_COMPARATOR | During the 4 week run-in period, patients remained on their respective pre-study dose of prednisone or equivalent. However, patients were standardized to 5 mg and 1 mg tablets of immediate release prednisone (Cortancyl). Patients were to take their tablets with or after the morning meal (at 8am +/- 30 minutes) for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Lodotra | DRUG | Administered with food at approximately 10 pm during the 4 week treatment period; patients received the identical dose of Lodotra as received of IR prednisone during the run-in period. |
| Cortancyl | DRUG | Administered in the morning with food during the 4 week run-in period; patients remained on their respective pre-study dose of prednisone or equivalent standardized to 5 mg and 1 mg tablets of immediate release (IR) prednisone (Cortancyl). |
Inclusion Criteria: * The subject must be able to understand the terms of the written informed consent form, and must provide a dated and signed form before the start of any study procedure * At least 18 years old * Patient having a diagnosis of asthma dating back more than 6 months at the time of ...