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

Primary Purpose

Lung Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Xolair
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Disease focused on measuring moderate to severe allergic asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Creighton University Division of Allergy & Immunology
  • Albany Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Xolair

Arm Description

Saline placebo

Xolair treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 29, 2005
Last Updated
January 6, 2014
Sponsor
Creighton University
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00139152
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University
Collaborators
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease
Keywords
moderate to severe allergic asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline placebo
Arm Title
Xolair
Arm Type
Experimental
Arm Description
Xolair treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal Saline
Intervention Description
Saline, Sub-Cuteanous (SQ)
Intervention Type
Drug
Intervention Name(s)
Xolair
Other Intervention Name(s)
omalizumab, rhumabE25
Intervention Description
Xolair, 0.016 mg/kg Immunoglobulions E (IgE) , SQ
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Townley, MD
Organizational Affiliation
Creighton University Division of Allergy & Immunology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhammad A Pasha, M.D.
Organizational Affiliation
Albany Medical CollegeDivision of Allergy, Asthma, & Immunology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University Division of Allergy & Immunology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States

12. IPD Sharing Statement

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

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