Azithromycin Treatment for the Airway Microbiome in Asthma

Asthma Chronic Clinical Trial

Official title:

The AZITRAMBA Trial: Azithromycin Treatment for the Airway Microbiome in Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03736629
• Other study ID #: IRB17-1287
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Asthma
• Asthma Chronic

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