Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma

PHASE4CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
Asthma
Interventions
DRUG

Omalizumab

Omalizumab was supplied as a sterile, freeze dried preparation, to be reconstituted to deliver 150mg of omalizumab. Each vial was reconstituted with 1.4ml of sterile water for injection. The appropriate dose and dosing frequency of omalizumab were determined by baseline total IgE and body weight. A dosing table was used following the European Summary of Product Characteristics (SmPC) of omalizumab.

DRUG

placebo

Placebo was a physiological salt solution, administered according to the same administration scheme to respect the same dosing frequency and injected volume.

Trial Locations (1)

Unknown

Novartis Investigator site, Rueil-Malmaison

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY