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

Completed · Phase 4

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00133042

Run by

University of Florida

People needed

16

Starts

2004-12-01

Expected to finish

2006-12-01

Last updated by the study team

2011-09-20

Who can join

Age: 6 and older, up to 26. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Florida Asthma Research Lab — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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