Azithromycin Treatment for the Airway Microbiome in Asthma

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

8 weeks of placebo capsule once daily by mouth

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Azithromycin

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

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

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

Non-asthmatic controls

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Azithromycin

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Zithromax

Eligibility Criteria

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Inclusion Criteria

1. Age 18 - 55 years
2. Able to provide informed consent
3. Smoking history \< 10 pack-years

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes