Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma

Novartis

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: placebo; Drug: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00454051

CIGE025AFR02

Details and patient eligibility

About

The aim of this study is to evaluate the expression of IgE high affinity receptors (the part of the cell associated with allergic response) in patients suffering from uncontrolled severe asthma despite long term treatment with high dose of inhaled corticosteroid and long acting Beta-2 agonist.

Full description

Double blind placebo controlled study to assess the expression of IgE on blood basophils and dendritic cells in patients with uncontrolled, severe, persistent allergic asthma after a 16-week Omalizumab treatment.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged >= 18 years.
• Patients with severe persistent allergic asthma with the following characteristics:
• FEV1 (Forced Expiratory Volume in One Second) <80% of predicted.
• Frequent daily symptoms (>=4 days/week on average) or nocturnal awakening (>=1/week on average).
• Multiple severe asthma exacerbations: either >=2 severe asthma exacerbations having required an unscheduled medical intervention with systemic corticosteroid in the past year, or hospitalization (including emergency room treatment) for an asthma exacerbation in the past year.
• Despite a high dose inhaled corticosteroid >1000 mg beclomethasone dipropionate or equivalent and a inhaled long-acting B2-agonist.
• With an allergy to a perennial allergen demonstrated with convincing criteria, i.e. positive prick skin test or in vitro reactivity to a perennial aeroallergen (RAST).
• Total serum IgE level >= 30 to <=700 IU/ml and suitable serum total IgE level and weight according to Xolair dosing tablets.

Exclusion criteria

• Age < 18 years.
• Smoking history > 20 pack years.
• Patients who have had an asthma exacerbation during the 4 weeks prior to randomization
• History of food or drug related severe anaphylactoid or anaphylactic reaction
• Elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis).
• Patients with active cancer, suspicion of cancer or any history of cancer.
• Pregnant women.
• Known hypersensitivity to omalizumab or to one of its components.
• Patients already treated with omalizumab (indeed a previous treatment with omalizumab could have modified the FceRI expression).
• Patients who had participated in a clinical trial in the past 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

Omalizumab

Active Comparator group

Description:

Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.

Treatment:

Drug: Omalizumab

Placebo

Placebo Comparator group

Description:

Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.

Treatment:

Drug: placebo