Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma

PHASE2CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

October 31, 2008

Study Completion Date

December 31, 2009

Conditions
Nasal PolyposisAsthma
Interventions
DRUG

Omalizumab

"Omalizumab (Xolair(R)) is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to human IgE. Molecular weight is approximately 149 kilodaltons. Xolair(R) is a sterile, white, preservative-free, lyophilized powder contained in a single-use vial, reconstituted with Sterile Water For Injection (SWFI), and administered as subcutaneous (SC) injection.~Xolair(R) will be administered subcutaneously in a dose of 75 to 375mg every 2 to 4 weeks. Doses (mg) and dosing frequency are determined by total serum IgE level (IU/ml) measured at the start of treatment and body weight (kg). During this 20-week during trial patients will receive 4 or 8 doses of omalizumab."

DRUG

Placebo

Placebo

Trial Locations (2)

3000

UZ Gasthuisberg, Leuven

9000

University Hospital, Ghent, Ghent

All Listed Sponsors
collaborator

Novartis Pharma AG, Switzerland

UNKNOWN

lead

University Hospital, Ghent

OTHER

NCT01393340 - Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma | Biotech Hunter | Biotech Hunter