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

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ClinicalTrials.gov Identifier: NCT00139152
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : January 7, 2014
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Creighton University

Study Description
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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
Lung Disease Drug: Placebo Drug: Xolair 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
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Study Type : Interventional  (Clinical Trial)
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 : September 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Saline placebo
 Drug: Placebo
Saline, Sub-Cuteanous (SQ)
Other Name: Normal Saline
Experimental: Xolair
Xolair treatment
 Drug: Xolair
Xolair, 0.016 mg/kg Immunoglobulions E (IgE) , SQ
Other Names:
  • omalizumab
  • rhumabE25


Outcome Measures
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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. [ Time Frame: 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. [ Time Frame: post dose ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139152


Locations
United States, Nebraska
Creighton University Division of Allergy & Immunology
Omaha, Nebraska, United States, 68131
United States, New York
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00139152     History of Changes
Other Study ID Numbers: Xolair ENO EBC Study
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

Keywords provided by Creighton University:
moderate to severe allergic asthma

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Omalizumab
 Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents