Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma
Condition: Severe IgE-mediated Asthma
MeSH terms: Asthma
Intervention: Omalizumab; Budesonide; Formoterol; Budesonide; Formoterol
Intervention description: Subcutaneous injection dose according to the IgE level and body weight.; Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose.; Formoterol 12ug tablets taken orally according to maximum daily dose.; Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.; Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.
Intervention MeSH terms: Omalizumab; Budesonide; Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 6 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the
      use of inhaled corticosteroid (ICS) in pediatric and adult participants with severe
      Immunoglobulin E (IgE)-mediated asthma inadequately controlled with high doses of
      corticosteroids.
    

Eligibility criteria:

        Inclusion Criteria

          -  Male and female between 6 and 55 years old. If female, participant of childbearing
             potential must use a safe and efficacious birth control method.

          -  Asthma is considered as not well-controlled if participant has 3 or more of the
             following conditions:

               1. Persistent day symptoms with current therapy twice at week or more, (siblings,
                  dyspnea, cough, chest pain, thoracic oppression).

               2. One or more night-time awakenings over the last 4 weeks.

               3. Any limitation of age-appropriated habitual activities.

               4. Need of rescue medication (short acting β2 agonist) for two or more occasions per
                  week during the last 4 weeks before screening and 2 consecutive weeks within the
                  4 weeks before selection.

               5. Peak expiratory flow (PEF) or VEF1 <80% predicted or personal best (if known)
                  this is not mandatory for pediatric participants (under 18 years old).

          -  Despite continuous treatment with high-dose inhaled corticosteroids (ICS) or oral
             corticosteroids (OCS) (CSO≥ 1 mg/kg/day) with or without controllers (As per GINA 2012
             definition), the subject is receiving high doses of ICS (budesonide or its equivalent)
             and a long-acting β2-agonists(LABA) (formoterol) for the past 12 weeks at visit 0.

          -  At last one documented asthma exacerbation (defined as increase asthma symptoms
             requiring systemic corticosteroid rescue therapy) that requires visits to the
             emergency room or to be hospitalized in the past 12 months. It is also considered
             asthma exacerbation a non-planned visit that required rescue medication (β2-agonists
             and/or steroid nebulization every 20 minutes or β2-agonists inhaler shots every 20
             minutes).

          -  Positive skin test or in vitro reactivity to a perennial aeroallergen, documented
             during the 12 months previous screening.

          -  IgE total concentration ranging from 30 to 1500 UI/ml.

          -  Body weight between 20 to 150 kg Exclusion Criteria

          -  Pregnant or lactating female or without safe and efficacious birth control method if
             of childbearing potential.

          -  Currently smokers or history of smoking 10 or more packs per year.

          -  Ex-smokers with a history of more than 10 years of smoking. As an exception, a
             participant with this criterion will be considered as eligible if the FEV1
             reversibility of the first spirometry reaches 12%.

          -  Active lung disease other than asthma.

          -  Use of methotrexate, gold salts, troleandomycin, cyclosporine, immunosuppressants,
             gammaglobulin or any other type of monoclonal antibody used during the 6 months prior
             to the initial visit.

          -  Use of omalizumab during the 4 months prior to de screening visit.

          -  History of renal disease, cardiovascular disease, metabolic disease, hematologic
             disease, gastrointestinal disease, as well as immunodeficiency or cerebrovascular
             disease currently under treatment but not-controlled.

          -  History of hepatic, neurologic, oncologic or autoimmune disease.

          -  Participant under suspicion of having cancer.

          -  Participants with history of hypersensitivity to sucrose, histidine, polysorbate 20 as
             well as to monoclonal antibodies or gammaglobulin.

          -  Hypersensitivity to omalizumab or its excipients.

          -  Abnormal values of the blood chemistry laboratory tests, over 2 times the upper limit
             normal, that are considered clinically significant.

          -  Underage participant or any participant under vulnerable conditions who does not live
             with their parents or legal guardian.