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

NCT00624832 | Completed Phase 4 Results

• 1 other identifier: CIGE025A2210
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 6

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

Keywords

Asthma; allergen challenge; bronchoprovocation; Methacholine challenge; serum Immunoglobulin E; Nitric Oxide; skin prick test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients

  Week 0, Week 8 and Week 16

Study Arms (4)

Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)

EXPERIMENTAL

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 (Immunoglobulin E (IgE) = 700-2000 IU/mL)

EXPERIMENTAL

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 (Immunoglobulin E (IgE) = 301-699 IU/mL)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Xolair DRUG

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

Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL); Xolair (Immunoglobulin E (IgE) = 301-699 IU/mL); Xolair (Immunoglobulin E (IgE) = 700-2000 IU/mL)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead
• Genentech, Inc.: collaborator
• Tanox: collaborator

Study Sites (6)

Novartis Investigator Site

Berlin, Germany

Location

Novartis Investigator Site

Frankfurt, Germany

Location

Novartis Investigator Site

Munich, Germany

Location

Novartis Investigator Site

Groningen, Netherlands

Location

Novartis Investigator Site

Bloemfontein, South Africa

Location

Novartis Investigator Site

Durban, South Africa

Location

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis investigator site

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 18, 2008
• First Posted: February 27, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 19, 2011
• Results First Posted: February 14, 2011

Record last verified: 2011-04

Locations

DE (3); NL (1); ZA (2)