Status:
COMPLETED
A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels
Lead Sponsor:
Novartis
Collaborating Sponsors:
Genentech, Inc.
Tanox
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00624832
Start Date
February 1 2008
End Date
January 1 2009
Last Update
April 19 2011
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigator Site
Berlin, Germany
2
Novartis Investigator Site
Frankfurt, Germany
3
Novartis Investigator Site
Munich, Germany
4
Novartis Investigator Site
Groningen, Netherlands