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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 24 months

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

Death

100%

80%

60%

40%

20%

Study treatment Arm

Biannual Mass Oral Placebo

Biannual Mass Oral Azithromycin

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,539 Previous Clinical Trials

567,677 Total Patients Enrolled

Clinical TrialsStudy DirectorGenetech

2,199 Previous Clinical Trials

888,490 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elucidate what research has been completed involving the antibiotic Azithromycin?

"Presently, 54 clinical trials of Azithromycin are running with 17 in their final stages. Most of the studies take place in Albuquerque, New mexico; however 688 other sites are also conducting research into this medication."

Answered by AI

Are there any vacancies left in this medical trial?

"As of now, this medical trial is still accruing participants. The initial posting date was November 16th 2021 and the most recent update took place on November 8th 2022."

Answered by AI

In what disease states is Azithromycin typically employed?

"Azithromycin is a reliable medication for treating genital ulcer disease (GUD). It's also useful in addressing chlamydia, adult infections and cervicitis."

Answered by AI

Has Azithromycin been validated by the FDA?

"Since this is a phase 2 trial, with evidence of safety but no proof of efficacy, our team at Power gave Azithromycin a score of 2 on the safety scale."

Answered by AI

What is the maximum capacity of participants for this research project?

"Affirmative. According to information found on clinicaltrials.gov, this research study is actively seeking participants and was initially posted on November 16th 2021. As of now, 120 volunteers need to be sourced from 5 distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Of ¹²⁹XE MRI To Assess Disease Progression In Patients With COPD Treated With Or Without Azithromycin And Standard-of-Care Medications

2021. "A Study Of ¹²⁹XE MRI To Assess Disease Progression In Patients With COPD Treated With Or Without Azithromycin And Standard-of-Care Medications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04353661.