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

Phase 4

Completed

Brief 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)	Xolair	Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
Xolair (Immunoglobulin E (IgE) = 700-2000 IU/mL)	Xolair	Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
Xolair (Immunoglobulin E (IgE) = 301-699 IU/mL)	Xolair	Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
Placebo	Placebo	By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients	Week 8, Week 16	The EAR was defined as the maximum percent drop in forced expiratory volume in one second (FEV1) in the first 30 minutes after the challenge: EAR = 100\* \[ FEV1 (0) - Minimum FEV1 (10, 15, 30 min)\] / FEV1 (0). For FEV1 (0), the "best post saline (Control) FEV1" was used. The EAR was analyzed using a linear (ANCOVA) model with a fixed effect for treatment groups and the EAR from the baseline challenge was used as a covariate.

Secondary Outcome Measures

Name	Time	Method
Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients	Week 0, Week 8 and Week 16	Late-phase allergic response (LAR) was only determined for those patients who had an LAR \>= 15% at baseline allergen bronchoprovocation testing. For Forced Expiratory Volume, FEV1 (0), the "best post saline (Control) FEV1" was used. LAR (%) = 100\*\[FEV1 (0) - Minimum FEV1 (3-8h)\]/FEV1 (0).