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

A Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy of Xolair in an Allergen Bronchoprovocation Study in Asthmatic Populations Defined by Serum IgE Concentrations

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Xolair; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Novartis Investigator Site
  • Frankfurt, Germany
    • Novartis Investigator Site
  • Munich, Germany
    • Novartis Investigator Site
• Netherlands
  • Groningen, Netherlands
    • Novartis Investigator Site
• South Africa
  • Bloemfontein, South Africa
    • Novartis Investigator Site
  • Durban, South Africa
    • Novartis Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL); 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.	Drug: Xolair; Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
EXPERIMENTAL: Xolair (Immunoglobulin E (IgE) = 700-2000 IU/mL); 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.	Drug: Xolair; Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
EXPERIMENTAL: Xolair (Immunoglobulin E (IgE) = 301-699 IU/mL); 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.	Drug: Xolair; Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
PLACEBO_COMPARATOR: 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.	Drug: Placebo; Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients	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.	Week 8, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients	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).	Week 0, Week 8 and Week 16

Collaborators and Investigators

• Sponsor: Novartis
• Collaborators: Genentech, Inc.; Tanox

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): January 1, 2009
• Study Completion (ACTUAL): January 1, 2009

Study Registration Dates

• First Submitted: February 18, 2008
• First Submitted That Met QC Criteria: February 26, 2008
• First Posted (ESTIMATE): February 27, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 19, 2011
• Last Update Submitted That Met QC Criteria: April 12, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Asthma; Nitric Oxide; allergen challenge; skin prick test; Methacholine challenge; bronchoprovocation; serum Immunoglobulin E
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Omalizumab
• Other Study ID Numbers: CIGE025A2210