Conditions: Asthma
Keywords: Persistent Asthma EXTRA Xolair Difficult Breathing
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 850
Healthy volunteers: no

Brief summary:
This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting beta-agonists (LABA) with or without additional controller therapy.

Detailed description:

Arms:
arm 1: The subcutaneous dose of Xolair administered in this study was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.

Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.

Participants were permitted to use albuterol as rescue medicine throughout the study. arm 2: The subcutaneous dose of placebo administered in this study was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.

Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.

Participants were permitted to use albuterol as rescue medicine throughout the study.

Interventions: intervention 1: omalizumab (Xolair) intervention 2: placebo intervention 3: corticosteroids intervention 4: long-acting beta-agonists
Intervention descriptions: intervention 1: Omalizumab (Xolair) was administered by subcutaneous (SC) injection every 2 or 4 weeks. Xolair was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that were reconstituted with Sterile Water for Injection (SWFI), USP. intervention 2: Placebo was administered by subcutaneous (SC) injection every 2 or 4 weeks. Placebo contained the same ingredients as the lyophilized formulation of Xolair,excluding omalizumab. intervention 3: Minimum dose of 500 µg of fluticasone dry-powder inhaler or its equivalent ex-valve dose twice a day. intervention 4: 50 µg salmeterol twice daily or 12 µg formoterol twice daily.

Protocol document: