A randomized, double-blind, placebo-controlled study to demonstrate the efficacy of Xolair in an allergen bronchoprovocation study in two asthmatic populations defined by serum IgE concentrations

• Conditions: Asthma

• Registration Number: EUCTR2007-001013-41-NL
• Lead Sponsor: ovartisPharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Male or female (post menopausal or surgically sterilized or using approved barrier or hormonal contraception) patients with intermittent, mild persistent or moderate persistent, aged 18-65 years.

Diagnosis with asthma with FEV1 of = 65% (pre-bronchodilator) of the predicted value for height, race, age, and sex.

Asthma exacerbation-free for = 4 weeks

Otherwise healthy patients except for diagnoses related to allergy or asthma

Body weight between 40 and 150 kg

24 subjects in Group 1 will have IgE levels between 30 IU/mL and 300 IU/mL; 24 subjects in Group 2 will have IgE levels between 700 IU/mL and 2000 IU/mL; 10 patients in Group 3 will have IgE levels between 301 IU/mL and 699 IU/mL and bodyweight = 150 kg.

Patients must have well-characterized positive skin reactivity to a specific allergen within 2 years prior to screening (this allergen will be used for bronchoprovocation testing).

Patients must also demonstrate a PD20 response to methacholine in the inhaled bronchoprovocation test prior to participating in allergen bronchoprovocation testing (ABP)

Patients must demonstrate a PD20 response to an aeroallergen in the graded ABP at screening.

Be able to provide written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Current active smokers with =5 pack-year smoking history

Asthma exacerbation requiring treatment with oral or IV corticosteroids in the past 3 months

Medical conditions that may interfere with the performance of spirometry or may pose a potential hazard from performing spirometry.

Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study.

History of asthma attack requiring a visit to an emergency room in the 6 weeks before or during Screening

History of asthma attack requiring treatment with intubation and mechanical ventilation in the 12 months before Day 1

History of clinically significant drug allergy. A known hypersensitivity to the study drug or drugs similar to the study drug.

History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.

A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

History of intolerance to methacholine or allergen bronchoprovocation

Elevated IgE due to suspected parasitosis

History of bleeding disorders; prior serious bleeding, low platelet counts, anticoagulant

Allergen Immunotherapy may not be started during this study. It is permitted to continue ongoing allergen immunotherapy at stable doses during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified