Azithromycin Treatment for the Airway Microbiome in Asthma



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 55
Updated:4/6/2019
Start Date:February 1, 2019
End Date:February 2020
Contact:Steve White, MD
Email:swhite@medicine.bsd.uchicago.edu
Phone:773-702-2004

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The AZITRAMBA Trial: Azithromycin Treatment for the Airway Microbiome in Asthma

The purpose of this study to determine whether the bacteria inside the lungs of people with
asthma can be modified (changed) if they are given an antibiotic and if this change is
associated with an improvement in asthma symptoms.


Inclusion criteria (All participants):

1. Age 18 - 55 years

2. Able to provide informed consent

3. Smoking history < 10 pack-years

Inclusion Criteria for subjects with poorly controlled asthma

1. Methacholine PC20 < 16 mg/ml or

2. Albuterol response > 12% on FEV1 after 4 puffs of albuterol

3. Ability to use combination ICS + LABA

4. Meet definition for Th2-low asthma: peripheral blood eosinophil count < 300 and
exhaled nitric oxide level < 30 ppb.

Exclusion Criteria (All participants)

1. History of allergy or intolerance to any medications used in this study

2. Medication exclusions:

1. Current use of medications that prolong QTc interval

2. Current use of omalizumab or other ant-IgE therapies

3. Current use of anti IL 5 therapies

4. Current use of anticoagulants

5. Prednisone or other oral steroids within past 3 months 3. Pregnancy or lactation 4.
Other respiratory or inflammatory disorders (e.g., sarcoidosis, emphysema) 5. Pre-existing
liver disease (AST or ALT >10% above the upper limit of normal) 6. Smoking within the last
6 months 7. Exacerbation of asthma in past 3 months 8. Affected by a hearing disorder 9.
Clinically significant medical condition (e.g., heart failure, seizure disorder) which may
in-crease risk as determined by study investigator 10. Corrected QT interval > 450 msec.
Patients with known cardiac history or prolonged QT interval on a screening EKG are
excluded given the small but real potential for macrolide-related side effects.
We found this trial at
2
sites
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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303 East Superior Street
Chicago, Illinois 60611
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