Clinical trial NCT03736629: Azithromycin Treatment for the Airway Microbiome in Asthma
Official title: The AZITRAMBA Trial: Azithromycin Treatment for the Airway Microbiome in Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Asthma Chronic
Keywords: Asthma
Azithromycin
Microbiome
Sputum
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2018-11-09
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Asthma Control Test (ACT) Score Change From Baseline Over 8 Weeks
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Forced Expiratory Volume (FEV1) Change From Baseline Over 8 Weeks
timeFrame: 8 weeks
measure: Sputum Eosinophils Change From Baseline Over 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Sputum Neutrophils Change From Baseline Over 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Number of Participants With Diary Event or Serious Asthma Exacerbation Over 8 Weeks
timeFrame: 8 weeks
measure: Microbiome Shannon Alpha-diversity Score Change From Baseline to 8 Weeks
timeFrame: 8 weeks
measure: Microbiome Beta-diversity Score Change From Baseline to 8 Weeks
timeFrame: 8 weeks
measure: Microbiome Change in Relative Proportion of Top 10 Genera From Baseline to 8 Weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Steve White, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 development. Respir Med. 2020 Nov;173:106175. doi: 10.1016/j.rmed.2020.106175. Epub 2020 Sep 28.