Clinical trial NCT00624832: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
allergen challenge
bronchoprovocation
Methacholine challenge
serum Immunoglobulin E
Nitric Oxide
skin prick test
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
name: Tanox
First posted: 2008-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients
timeFrame: Week 8, Week 16
Secondary outcomes:
measure: Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients
timeFrame: Week 0, Week 8 and Week 16
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigator Site
city: Frankfurt
country: Germany
facility: Novartis Investigator Site
city: Munich
country: Germany
facility: Novartis Investigator Site
city: Groningen
country: Netherlands
facility: Novartis Investigator Site
city: Bloemfontein
country: South Africa
facility: Novartis Investigator Site
city: Durban
country: South Africa
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: