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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00139152
First received: August 29, 2005
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Lung Disease
Drug: Placebo
Drug: Xolair
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exhaled Breath Condensate and Nitric Oxide: Non-invasive Evaluation of Lung Disease After Treatment With Xolair

Resource links provided by NLM:


Further study details as provided by Creighton University:

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. [ Time Frame: post dose ] [ Designated as safety issue: No ]

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. [ Time Frame: post dose ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: September 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00139152     History of Changes
Other Study ID Numbers: Xolair ENO EBC Study
Study First Received: August 29, 2005
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
moderate to severe allergic asthma

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

ClinicalTrials.gov processed this record on July 20, 2014