A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma

PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

March 31, 2010

Study Completion Date

May 31, 2010

Conditions
Asthma
Interventions
DRUG

Lodotra

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.

DRUG

Cortancyl

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).

Trial Locations (1)

75018

Hôpital Bichat, Paris

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY