Study of Azithromycin Treatment Based on Mucus Changes in Patients with Chronic Obstructive Pulmonary Disease (COPD)

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What is this study about?

This study focuses on patients with Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that causes breathing difficulties and frequent chest infections. The research examines how azithromycin, an antibiotic medication, can be used to manage severe mucus production in COPD patients.

The study aims to compare two different approaches for prescribing azithromycin in COPD patients over a 12-month period. In one group, the medication will be prescribed based on standardized management when patients experience severe mucus symptoms. In the other group, the prescription will be based on analyzing the physical properties of the mucus.

During the study, participants will receive azithromycin tablets by mouth, with a maximum daily dose of 500 mg. Throughout the year-long study, patients will have regular check-ups to monitor their breathing symptoms, measure their lung function, and assess their quality of life. The study will track how often patients experience worsening of their COPD symptoms, known as exacerbations, which can range from mild to severe enough to require hospitalization.

1 Initial evaluation and monitoring

Your participation begins with a comprehensive evaluation of your chronic obstructive pulmonary disease (COPD)

The medical team will assess your lung function through tests including spirometry and plethysmography

You will complete several questionnaires about your symptoms and quality of life

2 Treatment assignment

You will be assigned to one of two treatment groups

Both groups may receive azithromycin (an antibiotic medication) based on different criteria

The medication will be taken by mouth when prescribed

3 Regular check-ups

You will attend check-ups at 3, 6, 9, and 12 months

Each visit includes lung function tests and questionnaires about your symptoms

Your mucus will be analyzed using a special device called Rheomuco

Blood tests will be performed at the start and end of the study

4 Monitoring of breathing problems

Throughout the 12-month period, any breathing difficulties will be recorded

These will be classified as mild (requiring no new medicine), moderate (requiring antibiotics or oral steroids), or severe (requiring hospital stay)

Your medication use will be tracked during the entire study

5 Final evaluation

At the end of 12 months, a final assessment will be conducted

This includes lung function tests, blood tests, and quality of life questionnaires

Your overall improvement will be evaluated based on breathing tests and number of breathing problems experienced during the study

Who Can Join the Study?

  • Age between 40 and 85 years
  • Must provide written and signed informed consent
  • Ability to attend all scheduled visits and complete all required test procedures
  • Must be covered by French social security system
  • Diagnosed with chronic obstructive pulmonary disease (COPD) for at least 1 year with:
    • Disease severity classified as GOLD class C or D (refers to specific severity levels of COPD)
    • History of 3 or more disease flare-ups of any severity in the past year, OR
    • At least 1 severe flare-up requiring hospital stay in the past year
  • Must be able to produce sputum (mucus from lungs) naturally or through medical assistance
  • Heart rhythm measurement (ECG) showing:
    • For men: QT interval less than 450 milliseconds
    • For women: QT interval less than 470 milliseconds
  • Must have either:
    • Normal hearing test results for their age, OR
    • No medical reasons preventing long-term use of azithromycin (as determined by an ear, nose, and throat specialist)

Who Cannot Join the Study?

  • Patients under 18 years of age or over 65 years of age
  • History of allergic reactions to azithromycin (the study medication)
  • Current pregnancy or breastfeeding
  • Participation in other clinical trials within the last 30 days
  • Inability to follow study procedures or attend follow-up visits
  • Severe heart conditions or abnormal heart rhythm
  • Severe liver disease
  • Current active infection requiring antibiotics
  • Use of medications that may interact with azithromycin
  • History of lung cancer or other active cancers
  • Severe mental health conditions that could affect participation
  • Unable to provide informed consent
  • Respiratory failure requiring mechanical ventilation (breathing machine)
  • Severe kidney disease requiring dialysis
  • History of organ transplantation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Montpellier Montpellier France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
03.02.2023

Trial locations

Investigated drugs:

Azithromycin is an antibiotic medication used to treat respiratory infections. In this trial, it is used to help patients with Chronic Obstructive Pulmonary Disease (COPD) who experience problems with mucus in their airways. The medication works by fighting bacteria and reducing inflammation in the airways, which can help prevent COPD exacerbations (sudden worsening of symptoms). It is administered when patients show signs of severe sputum production or when their mucus characteristics indicate the need for treatment.

Chronic Obstructive Pulmonary Disease (COPD) – A progressive respiratory condition that causes airflow blockage and breathing-related problems. The disease develops gradually as the airways become inflamed and the air sacs in the lungs are damaged. The main symptoms include breathing difficulty, cough, mucus production, and wheezing. The condition typically worsens over time, leading to increased breathing difficulties and more frequent respiratory issues. The disease affects the lungs’ ability to take in and release air properly, making everyday activities more challenging.

Trial ID:
2024-516172-15-00
NCT ID:
NCT04669270
Trial Phase:
Therapeutic exploratory (Phase II)

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