Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair
This study is ongoing, but not recruiting participants.
Sponsor:
Creighton University
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00139152
First received: August 29, 2005
Last updated: July 3, 2012
Last verified: July 2012
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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 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 ]
| Estimated Enrollment: | 48 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Saline placebo
|
Drug: Placebo
Saline, SQ
Other Name: Normal Saline
|
|
Experimental: Xolair
Xolair treatment
|
Drug: Xolair
Xolair, 0.016 mg/kg IgE , SQ
Other Names:
|
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
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: | July 3, 2012 |
| 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 June 17, 2013