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OpenTrials
Completed

NCT Number: NCT00624832

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 was intended to demonstrate that patients with standard and high immunoglobulin E (IgE) levels can be protected from allergen induced broncho-constriction by Xolair

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigator Site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xolair

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients

    Time frame: Week 8, Week 16

    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 outcomes

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

    Time frame: Week 0, Week 8 and Week 16

    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).

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Genentech, Inc.
  • Tanox

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 27, 2008
Registry last updated
Apr 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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