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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Xolair
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, allergen challenge, bronchoprovocation, Methacholine challenge, serum Immunoglobulin E, Nitric Oxide, skin prick test

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

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

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

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

Placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
February 18, 2008
Last Updated
April 12, 2011
Sponsor
Novartis
Collaborators
Genentech, Inc., Tanox
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1. Study Identification

Unique Protocol Identification Number
NCT00624832
Brief Title
A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis
Collaborators
Genentech, Inc., Tanox

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, allergen challenge, bronchoprovocation, Methacholine challenge, serum Immunoglobulin E, Nitric Oxide, skin prick test

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)
Arm Type
Experimental
Arm Description
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.
Arm Title
Xolair (Immunoglobulin E (IgE) = 700-2000 IU/mL)
Arm Type
Experimental
Arm Description
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.
Arm Title
Xolair (Immunoglobulin E (IgE) = 301-699 IU/mL)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Xolair
Intervention Description
Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.
Primary Outcome Measure Information:
Title
Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients
Description
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.
Time Frame
Week 8, Week 16
Secondary Outcome Measure Information:
Title
Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients
Description
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).
Time Frame
Week 0, Week 8 and Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis investigator site
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigator Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigator Site
City
Frankfurt
Country
Germany
Facility Name
Novartis Investigator Site
City
Munich
Country
Germany
Facility Name
Novartis Investigator Site
City
Groningen
Country
Netherlands
Facility Name
Novartis Investigator Site
City
Bloemfontein
Country
South Africa
Facility Name
Novartis Investigator Site
City
Durban
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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