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Anti-viral Effects of Azithromycin in Patients With Asthma and COPD

NCT04319705 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-07-26

No results posted yet for this study

Summary

The purpose of this study is to investigate the anti-viral effects of low-dose AZM treatment in patients with asthma and COPD with an exacerbation history.

The investigators expect that long-term treatment with low dose AZM modulates the immune response to viral infections, with an increased interferon release, in patients with asthma and COPD with an exacerbation history. In addition, the investigators expect a decrease in inflammatory cells and mediators, and changes in bacteria, measured in samples from the lungs.

Half of the participants will receive azithromycin on top of their regular asthma/COPD treatment, while the other half will receive placebo on top of their regular asthma/COPD treatment.

Conditions

  • Asthma
  • COPD
  • Exacerbation Copd
  • Asthma; Eosinophilic
  • Bronchial Diseases
  • Lung Diseases, Obstructive
  • Lung Diseases
  • Immune System Diseases

Interventions

DRUG

Azithromycin

Azithromycin, 500mg, 3 times per week, 12-week treatment period, administered orally

DRUG

Placebo oral tablet

capsule containing placebo, 3 times per week, 12-week treatment period, administered orally

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Herlev and Gentofte Hospital

    collaborator OTHER

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Celeste Porsbjerg, MD, PhD · University Hospital Bispebjerg and Frederiksberg

  • Therese S Lapperre, MD, PhD · University Hospital Bispebjerg and Frederiksberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2022-03-31
Completion
2022-12-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04319705 on ClinicalTrials.gov