Effect of Anti-IgE in Non-Allergic Asthma
Asthma
About this trial
This is an interventional treatment trial for Asthma focused on measuring 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
Sites / Locations
- Johns Hopkins Asthma and Allergy Center
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Omalizumab
water injection
Other Names: Xolair 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE.