Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Omalizumab; Placebo; Fluticasone
Intervention description: The omalizumab dose administered, based on the patient's body weight and total serum IgE level at Screening, and the number of injections and injection volume was determined from the dosing tables in the protocol. Omalizumab 75 to 375 mg was administered subcutaneous (SC) every 2 or 4 weeks depending on the dose.; Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol.; Patients entered the study using their current formulation of any inhaled steroid (proprietary drug and device) ≥ 200 μg/day equivalent of fluticasone administered with a dry-powder inhaler.
Intervention MeSH terms: Fluticasone; Omalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 628.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: allergic; asthma; atopic; omalizumab; immunoglobulin E; IgE; anti-IgE

Summary:

      A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key
      role in generating asthma attacks. In patients with allergies, there is an exaggerated
      production of IgE in response to specific substances such as pollens. Omalizumab is a new
      drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against
      asthma attacks in children with allergic asthma.
    

Eligibility criteria:

        Inclusion criteria:

          -  Parent or legal guardian was informed of the study procedures and medications and gave
             written informed consent.

          -  Outpatient males and females aged 6 - < 12 years on study entry, with body weight
             between 20 and 150 kg.

          -  Total serum IgE level ≥ 30 to ≤ 1300 IU.

          -  Diagnosis of allergic asthma ≥ 1 year duration, according to American Thoracic Society
             (ATS) criteria, and a screening history consistent with clinical features of moderate
             or severe persistent asthma according to National Heart Lung and Blood Institute
             (NHLBI) guidelines.

          -  Positive prick skin test to at least one perennial allergen, documented within the
             past 2 years or taken at Screening. A radioallergosorbent test (RAST) could have been
             performed for patients with a borderline skin prick test result after consultation
             with Novartis clinical personnel.

          -  Patients with ≥ 12% increase in forced expiratory volume in 1 second (FEV1) over
             starting value within 30 minutes of taking up to 4 puffs (4x100 µg) salbutamol
             (albuterol) or nebulized salbutamol up to 5 mg (or equivalent of alternative
             B2-agonist) documented within the past year, at screening, during the run-in period,
             or prior to randomization. Patients were not to take their long acting B2-agonist
             (LABA) medication within 12 hours of reversibility testing.

          -  Clinical features of moderate or severe persistent asthma (at least step 3) despite
             therapy at step 3 or 4 (at least medium dose inhaled corticosteroid (ICS) -
             fluticasone dry-powder inhaler (DPI) ≥ 200 mg/day or equivalent with or without other
             controller medications).

          -  Documented history of experiencing asthma exacerbations and demonstrated inadequate
             symptom control during the last 4 weeks of run-in despite receiving an equivalent dose
             of fluticasone DPI ≥ 200 mg/day total daily ex-valve dose.

        Exclusion criteria:

          -  Patients who received systemic corticosteroids for reasons other than asthma,
             beta-adrenergic antagonists by any route, anticholinergics within 24 hours of
             Screening, methotrexate, gold salts, cyclosporin or troleandomycin, or had received
             desensitization therapy with less than 3 months of stable maintenance doses prior to
             Screening.

          -  Patients with a history of food or drug related severe anaphylactoid or anaphylactic
             reaction, a history of allergy to antibiotics, with aspirin or other non-steroidal
             anti-inflammatory drugs (NSAID)-related asthma (unless the NSAID could be avoided),
             with active lung disease or acute sinusitis/chest infection, elevated serum IgE levels
             for other reasons, presence/history of a clinically significant uncontrolled systemic
             disease, cancer, abnormal, electrocardiogram (ECG) in the previous month, or platelets
             ≤ 100 x 109/L or clinically significant laboratory abnormalities at Screening.