Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lodotra · 1 trial · 1 indication
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 ...
Lodotra is a small molecule being studied for the treatment of asthma. It is a modified-release tablet formulation of prednisone, a corticosteroid. In clinical development, it has been investigated specifically in patients with nocturnal asthma, a condition where asthma symptoms worsen at night.
Lodotra is a modified-release formulation of prednisone, a corticosteroid. Corticosteroids work by reducing inflammation in the airways, which helps to alleviate asthma symptoms. The modified-release design is intended to deliver the medication at a time that may better control nighttime symptoms.
Lodotra is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical research on this drug for the treatment of asthma.
Lodotra is in Phase 2 clinical development for asthma. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients.
Lodotra has been studied in one completed Phase 2 clinical trial, identified as NCT00686335. This trial, titled 'A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma,' enrolled 12 participants in France. The study was active-controlled and included adults aged 18 years and older.
Lodotra is a modified-release tablet formulation of prednisone. While the active ingredient is prednisone, Lodotra is a specific formulation designed to release the medication in a modified manner, potentially offering different pharmacokinetic properties compared to standard prednisone tablets.