Status:
TERMINATED
Non-invasive Measures of Effects of Xolair in Asthma
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Novartis
Genentech, Inc.
Conditions:
Asthma
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to look at the effectiveness of Xolair® (omalizumab) in people with asthma taking Advair Diskus®. The study will look at the effects of Xolair® on lung function using high...
Detailed Description
This is a prospective pilot study evaluating the effect of omalizumab on the small airways of moderate to severe asthmatic individuals who are not fully controlled on fluticasone/salmeterol 250/50 or ...
Eligibility Criteria
Inclusion
- Male or female aged 18 to 65 years, inclusive.
- History of moderate to severe asthma: Currently on a medium to high dose of an inhaled corticosteroid (ICS)and long-acting bronchodilator, and/or Criteria for medium dose of ICS as per GINA guidelines. ICS requirements are as follows: Beclomethasone HFA 80\* - 4 puffs/day; Budesonide DPI 180\*- 4 puffs/day; Budesonide/Fomoterol MDI\* - 4 puffs/day; Ciclesonide 80\* - 2 puffs/day; Ciclesonide 160\* - 2 puffs/day; Flunisolide CFC 250\* - 6 puffs/day; Fluticasone 110\* - 3 puffs/day; Fluticasone 220\* - 2 puffs/day; Fluticasone/salmeterol DPI 250/50 - 2 puffs/day; Fluticasone/salmeterol MDI 115/21 - 4 puffs/day; Fluticasone/salmeterol DPI 500/50 - 2 puffs/day; Fluticasone/salmeterol MDI 230/21 - 4 puffs/day; Triamcinolone\* - 10 puffs/day; Mometasone 110\* - 4 puffs/day; Mometasone 220\* - 2 puffs/day
- \* with a LABA (fometerol or salmeterol)
- FEV1 greater than/equal to 60% Hankinson predicted normal
- FEV1/FVC less than lower limit of normal Hankinson predicted
- Methacholine PC20 less than/equal to 8 mg/ml
- Be able to sign the Informed Consent Form.
- Positive skin test or a positive, in vitro response, to one relevant perennial aeroallergen (dog, cat, cockroaches, dermatophagoides farinae \[dust mite\], or dermatophagoides pteronyssinus) documented within the 12 months prior to screening or during the screening process (diameter of wheal greater than/equal to 3 mm vs. control).
- Meet the study drug-dosing table eligibility criteria (serum IgE level greater than/equal to 30 to less than/equal to 700 IU/mL and body weight greater than/equal 30 to less than/equal to 150 kg
Exclusion
- The use of the following medications will exclude subjects from entering the study: Oral or parenteral steroids- 6 months; Omalizumab- less than 12 months; Short and long-acting anticholinergics- Stop at time of run-in; Antileukotrienes, beta-adrenergic blocking agents, inhaled cromolyn sodium or nedocromil, macrolide antibiotics- Stop at time of run-in
- Tobacco within 1 year or \>5 pack years.
- Pregnant women, lactating women, or women of childbearing age not willing to take precautions to avoid becoming pregnant during the study.
- Subjects with upper respiratory infection or receiving an influenza vaccine within 6 weeks before the study.
- Subjects with a history of allergy or adverse reaction to inhaled beta2-agonists, methacholine, salmeterol, fluticasone, epinephrine or omalizumab or related classes of drug(s).
- Subjects with clinically significant evidence of cardiovascular, central nervous system, endocrine, gastrointestinal, hematopoietic, hepatic, renal, psychiatric, respiratory (other than asthma) disease, or any other severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Use of any other investigational agent in the last 30 days.
- Subjects with exacerbations during the run-in period that in the opinion of the investigator result in an unstable baseline
- Asthma totally controlled during the two weeks prior to omalizumab treatment. Total control is defined as: No days with symptom score \> 1; No use of rescue albuterol; PEF \> 80% predicted; No night-time awakening; No unscheduled physician or ED visits for asthma
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00784485
Start Date
February 1 2009
End Date
February 1 2011
Last Update
March 9 2011
Active Locations (1)
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1
UCLA
Los Angeles, California, United States, 90095