Lung Disease
Conditions
Keywords
moderate to severe allergic asthma
Brief summary
The purpose of this study is to study the effects of Xolair using non-invasive techniques from the expired gas of patients with moderate to severe allergic asthma.
Detailed description
Traditional methods of sampling secretions from the lower respiratory tract include sputum collection, sputum induction, and bronchoscopy with bronchoalveolar lavage. They cannot be repeated within a short period of time because of their invasiveness, and because the procedures themselves may include an inflammatory response. The need to monitor inflammation in the lungs has led to the exploration of exhaled gases and condensates. Noninvasive monitoring may assist in differential diagnosis of pulmonary diseases, assessment of disease severity and response to treatment.
Interventions
DRUGPlacebo
Saline, Sub-Cuteanous (SQ)
DRUGXolair
Xolair, 0.016 mg/kg Immunoglobulions E (IgE) , SQ
Sponsors
Novartis Pharmaceuticals
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* On medium to high dose inhaled corticosteroids either with or without a long acting beta agonist * Baseline IgE 30-700 IU/mL * Exhaled nitric oxide greater than 13 ppb * Positive skin test to at least one of the following perennial allergens: cat, dog, dust mite, cockroach * Stable asthma at the time of enrollment
Exclusion criteria
* Concurrent diseases/conditions, history of other diseases/conditions, with clinically significant uncontrolled systemic disease or a history of such disease (eg, infection, hematological, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinological, or gastrointestinal disease) within previous 3 months * Upper or lower respiratory tract infection within 6 weeks of screening visit * Elevated IgE level other than atopy * Known sensitivity to Xolair * \< 3 months of stable immunotherapy * Smokers * Pregnant/nursing women * Women of childbearing potential who are not practicing medically approved contraceptive methods (eg, oral, subcutaneous, mechanical, or surgical contraception) including abstinence * Patients who currently hav diagnosed cancer, are currently being investigated for possible cancer or who have any history of cancer * Known sensitivity to study drug or class of study drugs * Patients with 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of Xolair on exhaled nitric oxide and leukotriene levels obtained from exhaled breath condensate in patients before and after four months of Xolair or placebo treatment. | post dose |
Secondary
| Measure | Time frame |
|---|---|
| To measure the levels of power of hydrogen (pH), nitrate/nitrite in exhaled breath condensate before and after four months treatment with Xolair and to compare these data to those obtained from the placebo asthmatic control group. | post dose |
Countries
United States
Outcome results
None listed