Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair
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ClinicalTrials.gov Identifier: NCT00139152 |
Recruitment Status
:
Completed
First Posted
: August 31, 2005
Last Update Posted
: January 7, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Disease | Drug: Placebo Drug: Xolair | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Exhaled Breath Condensate and Nitric Oxide: Non-invasive Evaluation of Lung Disease After Treatment With Xolair |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
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:
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139152
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 |
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 |
Responsible Party: | Creighton University |
ClinicalTrials.gov Identifier: | NCT00139152 History of Changes |
Other Study ID Numbers: |
Xolair ENO EBC Study |
First Posted: | August 31, 2005 Key Record Dates |
Last Update Posted: | January 7, 2014 |
Last Verified: | January 2014 |
Keywords provided by Creighton University:
moderate to severe allergic asthma |
Additional relevant MeSH terms:
Lung Diseases Respiratory Tract Diseases Omalizumab |
Anti-Allergic Agents Anti-Asthmatic Agents Respiratory System Agents |