Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy
Condition: Persistent Allergic Asthma
MeSH terms: Asthma
Intervention: Omalizumab; Placebo
Intervention description: The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.; The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
Intervention MeSH terms: Omalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 616.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: omalizumab; asthma; immunoglobulin E; IgE

Summary:

      This study will assess the efficacy, safety and tolerability of omalizumab, compared to
      placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic
      asthma who have inadequate asthma control despite treatment according to GINA (2009) Step 4
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Met study drug-dosing table eligibility criteria (serum baseline total IgE level ≥ 30
             to ≤ 700 IU/mL and body weight > 20 kg and ≤ 150 kg)

          -  Diagnosed with asthma ≥ 1 year duration at Screening, and a history of asthma that is
             not adequately controlled with GINA (2009) Step 4 therapy

          -  Received medium-to-high dose inhaled corticosteroid > 500 µg Beclomethasone
             Diproprionate (BDP), or equivalent plus regularly inhaled LABA, either separately or
             in combination, for at least 8 weeks prior to screening

          -  Met specific asthma exacerbations eligibility criteria prior to the screening period

          -  Exhibited inadequate symptom control as demonstrated by specific criteria (in keeping
             with GINA 2009 guidelines)

          -  Positive skin prick test to at least one perennial aeroallergen documented by a
             historical test within 12 months prior to screening, or at Visit 1

          -  FEV1 ≥ 40% and < 80% of the predicted normal value for the patient (using local
             standards), after withholding bronchodilators at Visit 2

        Exclusion Criteria:

          -  Used other investigational drugs at the time of enrollment, or within 30 days or 5
             half-lives of enrollment, whichever is longer. For biological agent-based
             investigational drugs, such as monoclonal antibodies, at least six months will need to
             have passed between the last administration of the drug and the patient's Screening
             Visit.

          -  History of malignancy

          -  History of allergies and diseases that could interfere with the analyses

          -  Clinically significant abnormality on a 12-lead ECG recorded at Visit 1

          -  Elevated IgE levels for reasons other than allergy

          -  Current smokers, or a former smoker with a smoking history of > 10 pack-years. A
             former smoker must have abstained for a minimum of 12 months before randomization

          -  Receiving specific medications

          -  Clinically significant laboratory abnormalities (not associated with the study
             indication) at Visit 1

        Other protocol-defined inclusion/exclusion criteria may apply