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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

12 criteria

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 trial?

15 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Universitaire De Bordeaux
Verified
Bordeaux, France
Centre Hospitalier Universitaire De Montpellier
Verified
Montpellier, France
Oncopole Claudius Regaud
Verified
Toulouse, France

Trial locations

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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.

Azithromycin Dihydrate

What is already known about the treatment

Azithromycin – A widely used antibiotic medication that belongs to the macrolide class, administered orally in tablet form or through intravenous injection. This medication is currently well-established in medical practice and extensively documented in medical literature for treating various bacterial infections, including its specific use in Chronic Obstructive Pulmonary Disease (COPD) exacerbations. It works by binding to the 50S ribosomal subunit of bacteria, thereby inhibiting protein synthesis and preventing bacterial growth, while also demonstrating anti-inflammatory properties that are particularly beneficial in respiratory conditions. In COPD management, it's specifically used to prevent exacerbations and improve quality of life by reducing inflammation and controlling bacterial colonization in the airways.

Investigated diseases

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.