Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations

Summary

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

• Chronic Obstructive Pulmonary Disease

Interventions

DRUG

Azithromycin Pill

Participants will take azithromycin according to their standard of care prescription. If the participant is on the seasonal azithromycin treatment arm, they will only take azithromycin during the winter months (October-March) followed by matched placebo (April-September).

DRUG

Placebo

The placebo tablets will be matched in appearance, taste and smell to the azithromycin tablets.

Sponsors & Collaborators

• University of Aberdeen

  collaborator OTHER

• NHS Greater Glasgow and Clyde

  collaborator OTHER

• University of East Anglia

  collaborator OTHER

• Nottingham City Hospital

  collaborator UNKNOWN

• Swansea University

  collaborator OTHER

• Newcastle University

  collaborator OTHER

• University of Cambridge

  collaborator OTHER

• NHS Sunderland Clinical Commissioning Group

  collaborator UNKNOWN

• Liverpool School of Tropical Medicine

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• University College London Hospitals

  collaborator OTHER

• Liverpool Heart and Chest Hospital NHS Foundation Trust

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• Red Graphic

  collaborator UNKNOWN

• Eramol (UK) Ltd.

  collaborator UNKNOWN

• WGK Clinical Services Ltd.

  collaborator UNKNOWN

• Sealed Envelope Ltd.

  collaborator UNKNOWN

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Dr Ian B Wilkinson

  lead OTHER

Principal Investigators

• Ian B Wilkinson · University of Cambridge & University of Cambridge NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-05

Primary Completion

2028-06-30

Completion

2028-11-30

FDA Drug

Yes

Countries

• United Kingdom

Study Locations