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

NCT ID: NCT00624832

Last Updated: 2011-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-01-31

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

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Xolair

Intervention Type: DRUG

Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;

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.

Group Type: EXPERIMENTAL

Xolair

Intervention Type: DRUG

Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;

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.

Group Type: EXPERIMENTAL

Xolair

Intervention Type: DRUG

Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.

Interventions

Xolair

Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;

Intervention Type: DRUG

Placebo

Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Tanox

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Novartis investigator site

Locations

Novartis Investigator Site

Berlin, , Germany

Novartis Investigator Site

Frankfurt, , Germany

Novartis Investigator Site

Munich, , Germany

Novartis Investigator Site

Groningen, , Netherlands

Novartis Investigator Site

Bloemfontein, , South Africa

Novartis Investigator Site

Durban, , South Africa

Countries

Germany; Netherlands; South Africa

Other Identifiers

CIGE025A2210

Identifier Type: -

Identifier Source: org_study_id