Overview

A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels

Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
0
Participant gender:
All
Summary
This study was intended to demonstrate that patients with standard and high immunoglobulin E (IgE) levels can be protected from allergen induced broncho-constriction by Xolair
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis
Collaborators:
Genentech, Inc.
Tanox
Treatments:
Antibodies
Immunoglobulin E
Immunoglobulins
Omalizumab
Criteria
Inclusion Criteria:

- Male and female adult patients, body weight between 40-150 kg aged 18-65 years
(inclusive)

- Patients diagnosed with asthma with Forced Expiratory Volume (FEV1) ≥65% of the
predicted normal value for the patient

- Positive skin prick test to a specific allergen

- Patients had to demonstrate a Provocative Dose 20% FEV1 decline (PD20) response to an
aeroallergen in the graded allergen bronchoprovocation testing (ABP) at screening

Exclusion Criteria:

- Current active smokers

- Patients who have been hospitalized or had emergency treatment for an asthma attack in
the 12 months prior to study start

- History of bleeding disorders

- History of drug allergy

- Pregnant women or nursing mothers

- Females of childbearing potential, regardless of whether or not sexually active, if
they are not using a reliable form of contraception (surgical contraception or double
barrier methods (to be continued for at least two months following last dose) are
acceptable).

- Sexually active males who have not been sterilized and are not using a condom

- History of immunocompromise, including a positive HIV

- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

- History of drug or alcohol abuse within 12 months of study start

Other protocol-defined inclusion/exclusion criteria may apply