A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma (MONA)
|ClinicalTrials.gov Identifier: NCT00686335|
Recruitment Status : Completed
First Posted : May 29, 2008
Results First Posted : December 28, 2012
Last Update Posted : December 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Lodotra Drug: Cortancyl||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma|
|Study Start Date :||June 2008|
|Primary Completion Date :||March 2010|
|Study Completion Date :||May 2010|
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.
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.
Other Name: modified release tablet formulation of prednisone
Active Comparator: Cortancyl
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.
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).
Other Name: immediate release prednisone tablets
- Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment [ Time Frame: 4 weeks and 8 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686335
|Paris, France, 75018|
|Principal Investigator:||Michel Aubier, Prof. Dr.||Hôpital Bichat, Paris, France|