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

NCT ID: NCT00139152

Last Updated: 2014-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-12-31

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.

Conditions

Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Saline placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Saline, Sub-Cuteanous (SQ)

Xolair

Xolair treatment

Group Type: EXPERIMENTAL

Xolair

Intervention Type: DRUG

Xolair, 0.016 mg/kg Immunoglobulions E (IgE) , SQ

Interventions

Placebo

Saline, Sub-Cuteanous (SQ)

Intervention Type: DRUG

Xolair

Xolair, 0.016 mg/kg Immunoglobulions E (IgE) , SQ

Intervention Type: DRUG

Other Intervention Names

Normal Saline; omalizumab; rhumabE25

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Creighton University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert G Townley, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University Division of Allergy & Immunology

Muhammad A Pasha, M.D.

Role: PRINCIPAL_INVESTIGATOR

Albany Medical CollegeDivision of Allergy, Asthma, & Immunology

Locations

Creighton University Division of Allergy & Immunology

Omaha, Nebraska, United States

Albany Medical College

Albany, New York, United States

Countries

United States

Other Identifiers

Xolair ENO EBC Study

Identifier Type: -

Identifier Source: org_study_id