Azithromycin Treatment for the Airway Microbiome in Asthma

Phase 2

Terminated

• Conditions: Asthma Chronic
• Interventions: Drug: Placebo; Drug: Azithromycin

• Registration Number: NCT03736629
• Lead Sponsor: University of Chicago

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-09
• Study Start: 2019-02-01
• Primary Completion: 2021-03-01
• Study Completion: 2022-06-01
• Results First Submitted: 2022-11-23
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-03
• Last Update Submitted: 2023-08-03
• Results First Posted: 2023-08-23
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	8 weeks of placebo capsule once daily by mouth
Azithromycin	Azithromycin	8 weeks of Azithromycin (250 mg) capsule once daily by mouth

Primary Outcome Measures

Name	Time	Method
Asthma Control Test (ACT) Score Change From Baseline Over 8 Weeks	Baseline and 8 weeks	Score ranging from 0 to 40 indicating the degree of asthma symptoms. Lower score indicating worse asthma symptoms.

Secondary Outcome Measures

Name	Time	Method
Forced Expiratory Volume (FEV1) Change From Baseline Over 8 Weeks	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
Sputum Eosinophils Change From Baseline Over 8 Weeks	Baseline and 8 weeks	Percentage of 'eosinophils', an inflammatory cell seen in the airways of people with asthma, indicating the degree of inflammation
Sputum Neutrophils Change From Baseline Over 8 Weeks	Baseline and 8 weeks	Percentage of 'neutrophils', an inflammatory cell seen in the airways of people with asthma, indicating the degree of inflammation
Number of Participants With Diary Event or Serious Asthma Exacerbation Over 8 Weeks	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).
Microbiome Shannon Alpha-diversity Score Change From Baseline to 8 Weeks	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
Microbiome Beta-diversity Score Change From Baseline to 8 Weeks	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
Microbiome Change in Relative Proportion of Top 10 Genera From Baseline to 8 Weeks	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

Trial Locations

Locations (2)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States