A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Omalizumab; Placebo
Intervention description: Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.; Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Xolair; Allergic asthma; Cat allergy

Summary:

      This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with
      a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with
      placebo, reduces the degree of bronchoconstriction induced by environmental cat dander
      exposure in patients 18-65 years old with stable, moderate asthma and a history of cat
      dander-induced asthma symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent form.

          -  18 to 65 years of age and in general good health.

          -  History of moderate asthma, defined by the need for routine inhaled corticosteroids
             for at least the last 90 days prior to screening as well as the routine use of
             additional medication(s) (eg, short- or long-acting β2-agonists, leukotriene
             antagonist, or theophylline) to control asthma symptoms.

          -  History of cat dander-induced asthma in the 3 years prior to randomization.

          -  Cat exposure at the time of screening must remain constant throughout the duration of
             the study (eg, patients having cat exposure at home must continue to have regular
             exposure during the study; patients having no cat exposure at home must continue
             having no exposure at home during the study).

          -  Positive skin test to cat allergen, defined as a ≥ 5 mm wheal over the saline control
             wheal.

          -  Baseline forced expiratory volume in 1 second (FEV1) ≥ 70% predicted after withholding
             long-acting β2-agonists for > 36 hours and short-acting β2-agonists for > 6 hours.

          -  Eligibility per the study drug dosing table (serum IgE level ≥ 30 to ≤ 700 IU/mL and
             body weight ≥ 30 to ≤ 150 kg) and ability to be dosed per the dosing table.

          -  Less than 10 pack-years of smoking history.

          -  Demonstrated ≥ 20% fall in FEV1 during up to 1 hour of exposure in the cat
             environmental exposure chamber and ability to withstand exposure for at least 20
             minutes.

        Exclusion Criteria:

          -  Unstable asthma (defined as a hospitalization within the prior 6 months or an
             exacerbation requiring oral corticosteroids within 4 weeks of study entry).

          -  Life-threatening episode of asthma in the previous year.

          -  History of severe allergic reactions to cat exposure.

          -  Having undergone cat immunotherapy within 6 months prior to screening.

          -  Upper respiratory infection within 2 weeks of study entry.

          -  Active lung disease other than asthma.

          -  Significant medical illness other than asthma, including malignancies, parasitic
             infections, immune system disorders, and thrombocytopenia.

          -  History of hypersensitivity to the study drug or to drugs with similar chemical
             structures or to any ingredients, including excipients of the study medication or
             drugs related to omalizumab (eg, monoclonal antibodies, polyclonal gamma globulin).

          -  Documented medical history of anaphylaxis.

          -  Receipt of other investigational drugs within 30 days or 5 half-lives prior to
             screening, whichever is longer.

          -  Pregnant women and nursing mothers.

          -  Treatment with omalizumab within 12 months prior to screening.

          -  History of drug or alcohol abuse that, in the judgment of the investigator, may put
             the patient at risk for being unable to participate fully in the study.