Actively Recruiting

Phase 4
Age: 40Years +
All Genders
NCT05772013

Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations

Led by Dr Ian B Wilkinson · Updated on 2024-04-03

1311

Participants Needed

1

Research Sites

243 weeks

Total Duration

On this page

Sponsors

D

Dr Ian B Wilkinson

Lead Sponsor

U

University of Aberdeen

Collaborating Sponsor

AI-Summary

What this Trial Is About

People living with chronic obstructive pulmonary disease (COPD) may experience worsening of symptoms such as shortness of breath, cough and wheezing in addition to changes that may be expected for having COPD. The worsening of symptoms is called exacerbations or flare-ups and can be debilitating and frightening, requiring additional treatment, often with azithromycin. This is an antibiotic medicine that also has anti-inflammatory properties. It is prescribed as long-term prevention to reduce the risk of flare-ups. Some people may be affected by side effects from azithromycin. Antibiotic resistance is another concern, especially when using azithromycin for prevention rather than to treat active infection. It is currently unclear as to whether people should be advised to stop taking azithromycin once COPD has stabilised, or to stop it over the summer when fewer flare-ups happen. It is also not known if azithromycin is more effective in some people or more likely to cause side effects in others. Given these uncertainties, it is challenging to know how best to use azithromycin in managing COPD. Azithromycin is a valuable antibiotic, and should be prescribed where it has benefit but avoid unnecessary side effects and reduce the chances of bacteria becoming resistant to it. The purpose of this trial is to be able to gain results to answer these questions, and to establish the effects of stopping azithromycin in people whose COPD has stabilised, who have been taking it for at least 3 months. This trial will compare continuing azithromycin with stopping it completely, or stopping over the summer only, continuing over the winter. The investigators will compare the effects of these three treatments in the trial on flare-ups, symptoms and quality of life, and find out what factors may affect how individual participants respond to them.

CONDITIONS

Official Title

Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be able and willing to provide informed consent.
  • Have an established clinical diagnosis of COPD and be receiving prophylactic azithromycin for 25 (at least) 3 months to reduce COPD exacerbations.
  • Have a self-reported smoking history of 25 (at least) 10 pack years.
  • Be aged 25 40 years.
  • Have clinically stable COPD, i.e. no COPD exacerbation for at least 6 weeks.
Not Eligible

You will not qualify if you...

  • Known hypersensitivity to any of the trial drugs or excipients.
  • Current breast feeding, pregnancy or planned pregnancy during the trial.
  • Any medical history or clinically relevant abnormality that makes participant ineligible for inclusion because of a safety concern relating to continuing or discontinuing azithromycin or other considerations.
  • Known immunodeficiency requiring immunoglobulin/specific antibody therapy.
  • Azithromycin prophylaxis prescribed for non-COPD condition.
  • Active participation in COPD Clinical Trial of an Investigational Medicinal Product (CTIMP).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cambridge University Hospital NHS Trust, Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ

Actively Recruiting

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Research Team

Z

Zehra T Yilmaz

CONTACT

H

Heike Templin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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