Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Omalizumab; Inhaled corticosteroids (ICS); Long-acting beta 2-adrenergic agonist (LABA); Short-acting beta 2-adrenergic agonist (SABA)
Intervention description: Omalizumab 150 to 375 mg was administered subcutaneously every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of IgE.; Any ICS with proprietary drug and device > 500 mcg of fluticasone or equivalent; Fixed dose of LABA as prescribed prior to study entry; Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.
Intervention MeSH terms: Omalizumab; Terbutaline; Adrenergic Agents; Adrenergic Agonists
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma, anti-immunoglobulin E, omalizumab

Summary:

      This study investigated asthma-related quality of life in Brazilian patients using
      omalizumab.
    

Eligibility criteria:

        Inclusion criteria:

          -  12 to 75 years-old during screening visit.

          -  Body weight > 20 kg and < 150 kg.

          -  Daily or persistent asthma symptoms.

          -  Night symptoms at least once a week.

          -  Forced expiratory volume in 1 second (FEV1) > 40% and < 80% of predicted normal value
             and continuing asthma symptoms.

          -  FEV1 increased > 12% from baseline within 30 minutes of inhaled (up to 400 mcg) or
             nebulized (up to 5 mg) salbutamol.

          -  Subject taking more than 500 mcg/day of fluticasone or equivalent associated to a
             long-acting β2-agonist.

          -  Inhaled corticosteroid and long-acting beta-2 adrenergic agonist (LABA) doses that
             remained fixed during the last 12 weeks prior to screening.

          -  Medical history of at least two episodes of asthma exacerbation treated with systemic
             corticoid or at least one severe asthma exacerbation treated with systemic corticoid
             and hospitalization or emergency room visit in the last 12 months prior to screening.

          -  Positive skin prick test (diameter of wheal > 3mm) to at least one perennial
             aeroallergen (dust mite, cat/dog dander, cockroaches), to which the subject was likely
             to be exposed during the study.

          -  Subject capable to read and understand asthma related quality of life questionnaire
             (Juniper's questionnaire).

        Exclusion criteria:

          -  Pregnant, nursing female subjects.

          -  Female subjects without current acceptable contraceptive method.

          -  Previous history of allergy or hypersensitivity to omalizumab.

          -  Subjects with prior treatment with omalizumab.

          -  Subjects with medical history of psychiatric disorder.

          -  Subject had been treated with systemic corticosteroid for any reason other than
             asthma.

          -  Subject took β2 antagonist medication in the last 3 months prior to screening visit.

          -  Subject took protocol prohibited medication prior to screening.

          -  Medical history of food or drug related severe anaphylactoid reactions.

          -  Medical history of antibiotics allergy. Patients were included if the antibiotics to
             which they were allergic to were to be avoided for the entire duration of the study.

          -  Asthma related to non-steroidal anti-inflammatory drug (NSAID).

          -  Treatment of exacerbation in the 4 weeks prior to randomization.

          -  Other active lung diseases.

          -  Medical history of others uncontrolled diseases 3 months prior randomization (eg,
             infections, coronary heart diseases and metabolic diseases).

          -  Any history of cancer.

          -  Abnormal electrocardiogram (ECG), laboratory exams (clinically significant
             abnormalities), and chest X-ray (CXR).

          -  Evidence or history of drug or alcohol abuse.

          -  Airway infection (eg, pneumonia, acute sinusitis) 4 weeks prior to screening visit.

          -  Smokers or smoking history of > 10 pack-years.

          -  Subject that had been treated with investigational drugs over the past 30 days or
             during the course of the trial.

          -  Subject had elevated IgE levels for reasons other than allergy.

        Other protocol-defined inclusion/exclusion criteria applied to the study.