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 |
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.
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.
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