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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

August 29, 2005
January 6, 2014
September 2005
December 2009   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00139152 on ClinicalTrials.gov Archive Site
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 ]
To measure the levels of 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.
Not Provided
Not Provided
 
Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lung Disease
  • Drug: Placebo
    Saline, Sub-Cuteanous (SQ)
    Other Name: Normal Saline
  • Drug: Xolair
    Xolair, 0.016 mg/kg Immunoglobulions E (IgE) , SQ
    Other Names:
    • omalizumab
    • rhumabE25
  • Placebo Comparator: Placebo
    Saline placebo
    Intervention: Drug: Placebo
  • Experimental: Xolair
    Xolair treatment
    Intervention: Drug: Xolair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00139152
Xolair ENO EBC Study
No
Creighton University
Creighton University
Novartis Pharmaceuticals
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
Creighton University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP