Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Omalizumab; Optimized asthma therapy
Intervention description: Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level.; Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 406.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; omalizumab; Severe persistent allergic asthma

Summary:

      Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with
      severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to
      omalizumab over time will be assessed by physicians and patients evaluating the overall
      improvement in control of their asthma.

      THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who met the following criteria were included:

          -  Males or females of any race, who were 12-75 years of age

          -  A body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700
             IU/ml

          -  A diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic
             Society (ATS) criteria and at screening a history consistent with GINA (2204) step 3
             or 4 clinical features

          -  A positive prick skin test (diameter of wheal >= 3 mm) to at least one perennial
             allergen documented within the past 2 years or taken at visit 1

          -  Increase in FEV1 ≥12% over baseline value within 30 minutes of taking 2 to 4 puffs
             (2-4x100µg) salbutamol (albuterol) or nebulized salbutamol up to 5mg

          -  An FEV1 ≥ 40 and ≤ 80% of the predicted normal value for the patient at randomization

          -  Receiving moderate to high dose inhaled corticosteroid ≥ 800 µg BDP or equivalent and
             a regular inhaled long acting B-2 agonists for at least 3 months prior to screening
             and > 1000 µg (BDP) and a LABA for at least 4 weeks during the run-in and at
             randomization

          -  Patients who have suffered multiple (i.e. at least two) independent documented severe
             asthma exacerbations while receiving high doses of ICS (≥ 800 µg BDP or equivalent)
             plus regular inhaled LABA

          -  Evidence of poor asthma control at screening (based on patient history) and for at
             least 4 weeks immediately prior to randomisation

        Exclusion Criteria:

        Patients who met the following criteria were excluded:

          -  Had received systemic corticosteroids for reasons other than asthma within 4 weeks of
             Visit 1

          -  A smoking history >10 pack years

          -  An active lung disease other than allergic asthma

          -  Elevated serum IgE levels for reasons other than allergy

          -  Patients with significant underlying medical conditions