Effect of Omalizumab on Expression of IgE Receptors in Adults With Severe, Inadequately Controlled Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Omalizumab; placebo
Intervention description: Omalizumab was supplied as a sterile, freeze dried preparation, to be reconstituted to deliver 150mg of omalizumab. Each vial was reconstituted with 1.4ml of sterile water for injection. The appropriate dose and dosing frequency of omalizumab were determined by baseline total IgE and body weight. A dosing table was used following the European Summary of Product Characteristics (SmPC) of omalizumab.; Placebo was a physiological salt solution, administered according to the same administration scheme to respect the same dosing frequency and injected volume.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma, anti-immunoglobulin E, omalizumab, IgE receptors

Summary:

      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.
    

Eligibility criteria:

        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.