Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair

Creighton University

Status and phase

Completed

Phase 4

Conditions

Lung Disease

Treatments

Drug: Xolair

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00139152

Xolair ENO EBC Study

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.