Phase 4
Completed N=60
A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels
Source: ClinicalTrials.gov NCT00624832 ↗Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Feb 2011
Primary outcomePrimary: Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients — 9.3; 5.6; 23.1; 11.8 Percentage of EAR
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients |
9.3; 5.6; 23.1; 11.8; 5.1; 20.0 | — |
| SECONDARY Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients |
22.5; 25.7; 27.4; 5.3; -3.5; 19.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT00624832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.