Conditions: Asthma
Keywords: Asthma, anti-immunoglobulin E, omalizumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 116
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit. arm 2: Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.

Interventions: intervention 1: Omalizumab intervention 2: Inhaled corticosteroids (ICS) intervention 3: Long-acting beta 2-adrenergic agonist (LABA) intervention 4: Short-acting beta 2-adrenergic agonist (SABA)
Intervention descriptions: intervention 1: 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. intervention 2: Any ICS with proprietary drug and device \> 500 mcg of fluticasone or equivalent intervention 3: Fixed dose of LABA as prescribed prior to study entry intervention 4: Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.

Protocol document: