Effect of Anti-IgE in Non-Allergic Asthma

• Status: Terminated
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Genentech, Inc.
• Treatments: Omalizumab

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