A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)
Condition: Asthma
MeSH terms: Asthma
Intervention: omalizumab (Xolair); placebo
Intervention description: Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.; The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 333.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Omalizumab (Xolair); Atopic Asthma

Summary:

      This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study
      that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had
      elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1
      second (FEV1) ≥ 80% predicted, and were on inhaled corticosteroids with or without other
      controller asthma medications (e.g., long-acting β2-agonists [LABAs], leukotriene receptor
      antagonist [LTRA], or immunotherapy).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a documented history of asthma as well as evidence of ≥ 12% reversibility of
             FEV1. Evidence of ≥ 12% reversibility of FEV1 may be obtained by any one of the
             following measures: 1) Documentation of ≥ 12% reversibility of FEV1 after albuterol
             administration at any time during the preceding 24 months; 2) Documentation of ≥ 12%
             improvement in FEV1 with two separate measurements obtained within a 4-week period
             surrounding an asthma exacerbation during the preceding 24 months; 3) Demonstration of
             ≥ 12%reversibility of FEV1 after albuterol administration at the time of screening

          -  Have baseline FEV1 ≥ 80% predicted normal value prior to randomization

          -  Have a positive skin test (diameter of wheal ≥ 3 mm vs. control) or in vitro
             radioallergosorbent test (RAST(R)) or ImmunoCap(R) to one relevant perennial
             aeroallergen such as cat or house dust mites documented within the previous year

          -  Be receiving at least an inhaled corticosteroid dosage of fluticasone dry powder
             inhaler (DPI) ≥ 200 ug/day or equivalent ex-valve dose during the 12 weeks prior to
             the screening visit

          -  During the 4-week run-in period prior to randomization, demonstrate evidence of
             inadequate asthma symptom control despite inhaled corticosteroids with or without
             other controller asthma medications (e.g., LABA, LTRA, immunotherapy). Inadequate
             asthma symptom control is defined as at least one of the following reported on the
             subject diary card during the 4-week run-in period: Daytime asthma symptoms as a score
             of ≥ 1 (scale of 0-4) on at least 20 of 28 days (missing data to be treated as a day
             with no symptoms) and a mean symptom score of ≥ 1.5 (mean will be calculated based on
             only data supplied; missing values will not be considered) or Nighttime awakening
             because of asthma symptoms (more than 4 times during the 4-week run-in period)

          -  Meet the study drug-dosing table eligibility criteria (serum baseline IgE level ≥ 30
             to ≤ 1300 IU/mL and body weight ≥ 20 to ≤ 150 kg)

          -  If a female of childbearing potential, use an effective method of contraception (in
             the opinion of the investigator) to prevent pregnancy and agree to continue to
             practice an acceptable method of contraception for the duration of their participation
             in the study

        Exclusion Criteria:

          -  Have received chronic systemic corticosteroids (oral or intravenous) within 3 months
             or have received a burst of oral corticosteroids within the last 2 weeks prior to
             screening

          -  Have received Xolair therapy at any time within 12 months prior to screening

          -  Are pregnant or lactating

          -  Have a known hypersensitivity to any ingredients of Xolair, including excipients
             (sucrose, histidine, polysorbate 20)

          -  Have a lifetime history of smoking > 10-pack years

          -  Have active lung disease other than asthma (e.g., chronic bronchitis, emphysema,
             cystic fibrosis, chronic obstructive pulmonary disease)

          -  Have a history of upper respiratory infection or lower respiratory infection within
             the 30 days prior to randomization

          -  Have a diagnosis of aspirin or nonsteroidal anti-inflammatory drug-induced asthma

          -  Have taken immunosuppressants or other investigational drugs within the 30 days prior
             to screening

          -  Have a significant medical illness other than asthma