The Effect of Omalizumab on Airway Responsiveness to Adenosine in Patients With Poorly Controlled Asthma

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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 improve asthma control.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)