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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03736629
Other study ID # IRB17-1287
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date February 1, 2019
Est. completion date June 1, 2022

Study information

Verified date August 2023
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 17
Est. completion date June 1, 2022
Est. primary completion date March 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Northwestern University Chicago Illinois
United States University of Chicago Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Chicago Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Vogelmeier CF, Fuhlbrigge A, Jauhiainen A, Scheepers LEJM, Bengtsson T, Peterson S, Karlsson N, Sethi T, Locantore N, Tal-Singer R, Rennard S, Fageras M, Da Silva CA. COPDCompEx: A novel composite endpoint for COPD exacerbations to enable faster clinical — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and 8 weeks
Secondary 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 8 weeks
Secondary 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 Baseline and 8 weeks
Secondary 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 Baseline and 8 weeks
Secondary 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). 8 weeks
Secondary 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 8 weeks
Secondary 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 8 weeks
Secondary 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 8 weeks
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