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

Lung Disease Clinical Trial

Official title:

Exhaled Breath Condensate and Nitric Oxide: Non-invasive Evaluation of Lung Disease After Treatment With Xolair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139152
• Other study ID #: Xolair ENO EBC Study
• Status: Completed
• Phase: Phase 4
• First received: August 29, 2005
• Last updated: January 6, 2014
• Start date: September 2005
• Est. completion date: December 2009

Study information

• Verified date: January 2014
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases

Intervention

Drug:
• Placebo
Saline, Sub-Cuteanous (SQ)
• Xolair
Xolair, 0.016 mg/kg Immunoglobulions E (IgE) , SQ

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	Creighton University Division of Allergy & Immunology	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No