Effect of Anti-IgE in Non-Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: omalizumab; Placebo
Intervention description: 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE.; 150-375 milligrams depending on body weight and serum IgE.
Intervention MeSH terms: Omalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: asthma

Summary:

      The purpose of this study is to find out if omalizumab is effective in treating non-allergic
      asthma. The US Food and Drug Administration has approved the use of omalizumab to treat
      moderate to severe allergic asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and non-pregnant, non-breastfeeding females 18 through 80 years of age

          -  Clinically acceptable ECG

          -  Diagnosis of moderate to severe persistent asthma

          -  History or presence of episodic symptoms of airflow obstruction (wheeze, chest
             tightness, cough, shortness of breath)

          -  Airflow obstruction is at least partially reversible

          -  FEV1 in the context of this study is <80%of predicted values at visit 1 with no
             short-acting ß agonist use within 6 hours of spirometry

          -  Improvement of at least 12% of predicted FEV1 value and at least 200 ml within 15 to
             30 minutes of inhaling nebulized albuterol (up to 5mg) or 2-4 puffs of albuterol (90
             mcg/actuation) demonstrated at study entry or documented in the last year.

          -  Subjects must be able to demonstrate proper technique for use of the MiniWright peak
             flow meter

          -  Subjects must have a negative skin test to the 5 common perennial aeroallergens (D.
             farinae, D. pteronyssinus, cat, dog, and cockroach) at prick puncture with an adequate
             histamine control.

          -  Subjects must have negative RAST to the same 5 common perennial aeroallergens .

          -  Serum total IgE must be 30-700 IU/ml.

          -  Normal EKG at baseline

          -  Females must be: Surgically sterile (hysterectomy, bilateral oophorectomy, bilateral
             tubal ligation), OR postmenopausal (at least 1 year since last menses), OR using one
             of the following medically acceptable forms of birth control throughout the duration
             of the study:

               -  Systemic contraceptives

               -  Diaphragm with intravaginal spermicide

               -  Cervical cap

               -  Intrauterine device

               -  Condom with intravaginal spermicide

          -  Females in certain categories (not sexually active, vasectomized partner) will be
             admitted at the discretion of the investigator on a case-by-case basis. Accepted cases
             will be documented on the Female Enrollment Form and kept with the informed consent
             document.

          -  Females, excluding those more than 1 year postmenopausal or who are surgically
             sterile, must have a negative urine pregnancy test at Visit 1 and other visits
             specified in this protocol. If a subject becomes pregnant during the study
             participation, they will be discharged from the study and followed until termination
             of the pregnancy or delivery is complete.

        Exclusion Criteria:

          -  Respiratory tract infection within 14 days prior to Visit 1

          -  Chronic bronchitis, COPD, emphysema and other chronic lung diseases

          -  Receiving immunotherapy other than maintenance therapy

          -  Current smokers

          -  Current use of Xolair®

          -  Recent history of drug or alcohol abuse (within 3 years prior to Visit 1)

          -  Pregnant or likely to become pregnant during the study

          -  Breast-feeding

          -  History of hypersensitivity to albuterol, or Xolair, or to drugs with similar chemical
             structures

          -  Treatment with any investigational drug in the last 30 days before enrollment into the
             study (Visit 1)

          -  Clinically relevant cardiovascular, hepatic, neurologic, psychiatric, endocrine, or
             other major systemic disease making the protocol or interpretation of the study
             results difficult

          -  Site staff members or their immediate families are not eligible to enroll