Azithromycin Treatment for the Airway Microbiome in Asthma

The University of Chicago

Status and phase: Terminated; Phase 2

Conditions: Asthma Chronic

Treatments: Drug: Placebo; Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT03736629

IRB17-1287

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 PD 20 < 400 mcg/ml or albuterol response > 12% on FEV1 after 4 puffs of albuterol
2. Currently prescribed ICS + LABA
3. 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

3. Prednsione or other oral steroids within past 3 months

4. Pregnancy or lactation, or plans to become pregnant

5. Other respiratory or inflammatory disorders (e.g., sarcoidosis, emphysema)

6. Pre-existing liver disease by history

7. Smoking within the last 6 months

8. Exacerbation of asthma in past 3 months

9. Affected by a hearing disorder

10. Clinically significant medical condition (e.g., heart failure, seizure disorder) which may in-crease risk as determined by study investigator

11. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

8 weeks of placebo capsule once daily by mouth

Treatment:

Drug: Placebo

Azithromycin

Active Comparator group

Description:

8 weeks of Azithromycin (250 mg) capsule once daily by mouth

Treatment:

Drug: Azithromycin

Non-asthmatic controls

No Intervention group

Description:

Non-asthmatic controls to assess variability of microbiome composition and diversity over time in a normal population. No intervention given.