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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
8 weeks of Azithromycin (250 mg) once daily by mouth
Placebo
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Asthma Control Test (ACT) Score Change From Baseline Over 8 Weeks
Score ranging from 0 to 40 indicating the degree of asthma symptoms. Lower score indicating worse asthma symptoms.
Time frame: Baseline and 8 weeks
Forced Expiratory Volume (FEV1) Change From Baseline Over 8 Weeks
Volume of air exhaled in 1 second on a forced expiration, expressed as percent of predicted, indicating the degree of airflow obstruction in asthma
Time frame: 8 weeks
Sputum Eosinophils Change From Baseline Over 8 Weeks
Percentage of 'eosinophils', an inflammatory cell seen in the airways of people with asthma, indicating the degree of inflammation
Time frame: Baseline and 8 weeks
Sputum Neutrophils Change From Baseline Over 8 Weeks
Percentage of 'neutrophils', an inflammatory cell seen in the airways of people with asthma, indicating the degree of inflammation
Time frame: Baseline and 8 weeks
Number of Participants With Diary Event or Serious Asthma Exacerbation Over 8 Weeks
The outcome is derived from a weighted scoring system called CompEx that describes asthma symptoms recorded on a daily basis. Final result is a dichotomous outcome indicating whether the patient had a "diary event" based on changes in peak expiratory flow, reliever use, and asthma symptoms or a serious exacerbation (deterioration of asthma leading to oral corticosteroid use, emergency room admission, or hospital admission).
Time frame: 8 weeks
Microbiome Shannon Alpha-diversity Score Change From Baseline to 8 Weeks
A measure of the diversity of the bacteria in the sputum or oral sample; that is, how many different types of bacteria are present. This value decreases in severe asthma
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Time frame: 8 weeks
Microbiome Beta-diversity Score Change From Baseline to 8 Weeks
A second measure of the diversity of the bacteria in the sputum or oral sample; that is, how many different types of bacteria are present. This value decreases in severe asthma
Time frame: 8 weeks
Microbiome Change in Relative Proportion of Top 10 Genera From Baseline to 8 Weeks
A measure of how many of the top types of bacteria are present in the sputum or oral sample. Value changes with asthma
Time frame: 8 weeks