Status:
TERMINATED
Effect of Anti-IgE in Non-Allergic Asthma
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Asthma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Asthma is a chronic inflammatory disease of the lower airways. The inflammatory process is associated with changes in airway hyperresponsiveness (irritability), and airflow limitations caused by bronc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00162773
Start Date
April 1 2005
End Date
September 1 2009
Last Update
August 28 2017
Active Locations (1)
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1
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21224