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

Sponsor
Creighton University (Other)
Overall Status
Completed
CT.gov ID
NCT00139152
Collaborator
Novartis Pharmaceuticals (Industry)
65
Enrollment
2
Locations
2
Arms
51
Duration (Months)
32.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Exhaled Breath Condensate and Nitric Oxide: Non-invasive Evaluation of Lung Disease After Treatment With Xolair
Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Saline placebo

Drug: Placebo
Saline, Sub-Cuteanous (SQ)
Other Names:
  • Normal Saline

    		•
    Experimental: Xolair

    Xolair treatment

    Drug: Xolair
    Xolair, 0.016 mg/kg Immunoglobulions E (IgE) , SQ
    Other Names:
  • omalizumab
  • rhumabE25

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Creighton University Division of Allergy & Immunology Omaha Nebraska United States 68131
    2 Albany Medical College Albany New York United States 12208

    Sponsors and Collaborators

    • Creighton University
    • Novartis Pharmaceuticals

    Investigators

    • Principal Investigator: Robert G Townley, MD, Creighton University Division of Allergy & Immunology
    • Principal Investigator: Muhammad A Pasha, M.D., Albany Medical CollegeDivision of Allergy, Asthma, & Immunology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Creighton University
    ClinicalTrials.gov Identifier:
    NCT00139152
    Other Study ID Numbers:
    • Xolair ENO EBC Study
    First Posted:
    Aug 31, 2005
    Last Update Posted:
    Jan 7, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by Creighton University
    moderate to severe allergic asthma
    Additional relevant MeSH terms:
    Lung Diseases
    Omalizumab

    Study Results

    No Results Posted as of Jan 7, 2014