NCT03736629
Terminated
Phase 2
The AZITRAMBA Trial: Azithromycin Treatment for the Airway Microbiome in Asthma
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Asthma Chronic
- Sponsor
- University of Chicago
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Asthma Control Test (ACT) Score Change From Baseline Over 8 Weeks
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
8 weeks of placebo capsule once daily by mouth
Intervention: Placebo
Azithromycin
8 weeks of Azithromycin (250 mg) capsule once daily by mouth
Intervention: Azithromycin
Outcomes
Primary Outcomes
Asthma Control Test (ACT) Score Change From Baseline Over 8 Weeks
Time Frame: Baseline and 8 weeks
Score ranging from 0 to 40 indicating the degree of asthma symptoms. Lower score indicating worse asthma symptoms.
Secondary Outcomes
- Forced Expiratory Volume (FEV1) Change From Baseline Over 8 Weeks(8 weeks)
- Sputum Eosinophils Change From Baseline Over 8 Weeks(Baseline and 8 weeks)
- Sputum Neutrophils Change From Baseline Over 8 Weeks(Baseline and 8 weeks)
- Number of Participants With Diary Event or Serious Asthma Exacerbation Over 8 Weeks(8 weeks)
- Microbiome Shannon Alpha-diversity Score Change From Baseline to 8 Weeks(8 weeks)
- Microbiome Beta-diversity Score Change From Baseline to 8 Weeks(8 weeks)
- Microbiome Change in Relative Proportion of Top 10 Genera From Baseline to 8 Weeks(8 weeks)
Study Sites (2)
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