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