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

This study has been completed.
Sponsor:
Collaborators:
Genentech
Tanox
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00624832
First received: February 18, 2008
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Xolair
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients [ Time Frame: Week 8, Week 16 ] [ Designated as safety issue: No ]

    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:
  • Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients [ Time Frame: Week 0, Week 8 and Week 16 ] [ Designated as safety issue: No ]
    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).


Enrollment: 60
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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;
Other Name: Xolair
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;
Other Name: Xolair
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;
Other Name: Xolair
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624832

Locations
Germany
Novartis Investigator Site
Berlin, Germany
Novartis Investigator Site
Frankfurt, Germany
Novartis Investigator Site
Munich, Germany
Netherlands
Novartis Investigator Site
Groningen, Netherlands
South Africa
Novartis Investigator Site
Bloemfontein, South Africa
Novartis Investigator Site
Durban, South Africa
Sponsors and Collaborators
Novartis
Genentech
Tanox
Investigators
Principal Investigator: Novartis Novartis investigator site
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00624832     History of Changes
Other Study ID Numbers: CIGE025A2210
Study First Received: February 18, 2008
Results First Received: January 21, 2011
Last Updated: April 12, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
Asthma
allergen challenge
bronchoprovocation
Methacholine challenge
serum Immunoglobulin E
Nitric Oxide
skin prick test

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Immunoglobulin E
Immunoglobulins
Antibodies
Omalizumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Allergic Agents
Therapeutic Uses
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 28, 2014