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

January 6, 2014 updated by: Creighton University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University Division of Allergy & Immunology
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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
post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 31, 2005

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

January 6, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xolair ENO EBC Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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