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Macrolide Antibiotic

Azithromycin for Chronic Obstructive Pulmonary Disease

Phase 2
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 24 months
Awards & highlights

Study Summary

This trial will test whether azithromycin can help reduce exacerbations, improve lung function, and perfusion in people with COPD.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease (COPD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ¹²⁹XE MRI VDP from Baseline to 24 weeks
Rate of Moderate/Severe AEs
Rate of Moderate/Severe Exacerbation
Secondary outcome measures
Absolute Change in Pre-bronchodilator FEV-1 (Liters)
Number of Participant with Adverse Events With Severity Determined According To The World Health Organization (WHO) Toxicity Scale

Side effects data

From 2018 Phase 4 trial • 190238 Patients • NCT02047981
3%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Biannual Mass Oral Azithromycin
Biannual Mass Oral Placebo

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm A Open-label: azithromycin + SOC therapyExperimental Treatment2 Interventions
Participants will receive azithromycin and SOC theraphy for 52 weeks.
Group II: Arm A Open-label: SOC therapyActive Control1 Intervention
Participants will receive SOC theraphy for 52 weeks.
Group III: Arm B Observational: SOC therapyActive Control1 Intervention
Participants will receive SOC theraphy for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azithromycin
2018
Completed Phase 4
~274950

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,541 Previous Clinical Trials
568,019 Total Patients Enrolled
Clinical TrialsStudy DirectorGenetech
2,202 Previous Clinical Trials
890,024 Total Patients Enrolled
~3 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
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