Clinical trial NCT00139152: Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair
Official title: Exhaled Breath Condensate and Nitric Oxide: Non-invasive Evaluation of Lung Disease After Treatment With Xolair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Disease
Keywords: moderate to severe allergic asthma
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2005-08-31
Enrollment: 65
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: post dose
Secondary outcomes:
measure: 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.
timeFrame: post dose
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Division of Allergy & Immunology
state: Nebraska
city: Albany
country: United States
facility: Albany Medical College
state: New York
Study officials:
affiliation: Creighton University Division of Allergy & Immunology
name: Robert G Townley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albany Medical CollegeDivision of Allergy, Asthma, & Immunology
name: Muhammad A Pasha, M.D.
role: PRINCIPAL_INVESTIGATOR
References: