A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma (MONA)
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|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|
|Actual Primary Completion Date :||March 2010|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|