Status:
COMPLETED
The Effect of Omalizumab on Airway Responsiveness to Adenosine in Patients With Poorly Controlled Asthma
Lead Sponsor:
University of Florida
Conditions:
Asthma
Eligibility:
All Genders
6-26 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether the addition of omalizumab in patients with poorly controlled asthma (because of poor adherence) will decrease allergic airway inflammation and improv...
Detailed Description
Patients with moderate to severe allergic asthma who are poorly adherent to inhaled corticosteroids (ICS) have persistent airway inflammation that results in excessive morbidity and sometimes death. O...
Eligibility Criteria
Inclusion
- Non-smoking subjects
- 6-26 years of age
- Evidence of poor asthma control
- Adherence to ICS \< 50% of doses prescribed over a minimum of 3 months
- Baseline FEV1 \> 60% of predicted
- PC20 AMP \< 60 mg/ml
- Able to perform American Thoracic Society (ATS)-acceptable and reproducible spirometry
Exclusion
- Cigarette smoking/use of marijuana
- Pregnancy
- Respiratory infections in past six weeks
- History of acute allergic reaction to asthma/allergy medication
- Total dose requirement of omalizumab more than 375 mg every two weeks
- Inability to withhold required medications before challenge
- Abnormal electrocardiogram (ECG)
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00133042
Start Date
December 1 2004
End Date
December 1 2006
Last Update
September 20 2011
Active Locations (1)
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1
University of Florida Asthma Research Lab
Gainesville, Florida, United States, 32610