Non-invasive Measures of Effects of Xolair in Asthma
Asthma
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Respiratory Tract Diseases, Lung Diseases, Dyspnea
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- UCLA
Arms of the Study
Arm 1
Experimental
Xolair injections
All subjects receive active drug (Xolair-see 'interventions').