Clinical trial NCT00079937 (phase 3, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: omalizumab, placebo, fluticasone
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C
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.