Effect of Stopping Long‑Term Azithromycin in Stable Non‑Cystic Fibrosis Bronchiectasis Patients: A Randomized Controlled Trial

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What is this study about?

Bronchiectasis is a long‑term lung condition in which the airways become widened and damaged, leading to persistent cough, excess mucus, and frequent infections. Some patients with this condition have been taking a low‑dose antibiotic from the macrolides class, specifically azithromycin, for at least one year to help prevent these infections.

The purpose of the study is to determine whether stopping the low‑dose medication is not worse than continuing it. Participants are randomly assigned (by chance) to either stop the drug or keep taking it, and they are followed for up to two years. During this time they will have regular clinic visits where they answer quality‑of‑life questionnaires, undergo lung‑function tests such as FEV1 (the amount of air forced out in one second) and FVC (the total amount of air forced out), and have any worsening episodes, called exacerbations, recorded. The study aims to see if patients who stop the medication experience similar health outcomes compared with those who continue it.

1 enrollment and baseline assessment

after signing the consent form, you will be asked to provide information about your health, including a description of your bronchiectasis condition.

a series of tests will be performed to measure your lung function, such as the amount of air you can exhale in one second, and you will complete quality‑of‑life questionnaires that ask about daily symptoms and activities.

the results of these tests create the reference point for the rest of the study.

2 randomization

you will be assigned by a computer program to one of two groups without knowing which group you are in.

randomization means the assignment is made by chance, so the groups are comparable.

3 medication phase

if you are placed in the continuation group, you will keep taking the low‑dose macrolide that you have used for at least one year.

the tablet is azithromycin in a film‑coated form, usually 250 mg or 500 mg, taken orally as instructed by the study doctor, typically one tablet each day.

if you are placed in the discontinuation group, you will stop taking the azithromycin tablets and will not receive any replacement medication for the purpose of the trial.

4 monitoring for exacerbations

throughout the study you will be asked to note any worsening of breathing symptoms, fever, or need for extra antibiotics.

these episodes are called exacerbations and will be recorded by the study team to determine the time to first exacerbation and the total number of events.

5 12‑month follow‑up visit

approximately one year after randomization you will return for a scheduled visit.

the same lung function tests and quality‑of‑life questionnaires performed at baseline will be repeated.

samples may be taken to check for bacteria that are resistant to macrolides.

6 24‑month follow‑up visit (final assessment)

about two years after randomization you will attend the final study visit.

lung function, quality‑of‑life, and resistance testing will be performed again.

the data collected will be used to compare the outcomes of continuing versus stopping the low‑dose azithromycin.

Who Can Join the Study?

Be at least 18 years old, male or female.
Have bronchiectasis (damage and widening of the lung airways) confirmed by a thoracic CT‑scan (a detailed X‑ray picture of the chest).
Have taken the antibiotic Azithromycin (a low‑dose medicine that helps prevent infections) for at least 12 months.
Have had one or fewer pulmonary exacerbations (lung flare‑ups) in the last 12 months.
Have not had a severe lung flare‑up that required hospitalization due to respiratory failure (being admitted to hospital because breathing became very difficult) in the last 12 months.
Be part of the French health care system (covered by France’s public health insurance).
Be able to read, understand, and sign a written informed consent form that explains the study.

Who Cannot Join the Study?

Having a confirmed diagnosis of cystic fibrosis.
Having received a lung transplantation.
Having had an allogenic hematopoietic stem cell transplantation (a transplant of blood‑forming stem cells from a donor).
Being a woman who could become pregnant and not willing to use approved birth‑control methods such as hormonal contraception, an intrauterine device, tubal sterilisation, or reliable abstinence.
Being a man whose partner could become pregnant and not willing to use approved birth‑control methods such as condoms, vasectomy, or reliable abstinence.
Being a close relative of any doctor, nurse, pharmacist, or other study staff member.
Being in prison or otherwise deprived of liberty by a legal decision.
Being under legal guardianship or other legal supervision.
Having COPD (chronic obstructive pulmonary disease) or asthma as the main lung problem (unless bronchiectasis is the main problem).
Being pregnant or breastfeeding.
Currently taking part in another interventional clinical trial.
Having expected problems that would prevent the required study monitoring.
Using long‑term oxygen therapy or non‑invasive mechanical ventilation for chronic breathing failure (except CPAP for sleep apnea), having a lung function measure (FEV1) less than 30 % of the predicted value, or being considered for a lung transplant.
Having any reason that makes the use of azithromycin unsafe, such as allergy to macrolide antibiotics, sensitivity to any ingredient in the medication, taking other medicines that can lengthen the heart’s QT interval, low potassium or magnesium levels, very slow heart rate, serious heart rhythm problems or severe heart failure, kidney problems with creatinine clearance under 40 mL/min, taking drugs like ergotamine, cisapride, or colchicine, a QTc measurement over 450 ms for men or 470 ms for women, or severe liver disease.
Experiencing severe hemoptysis (coughing up a large amount of blood) from a lung cause.
Having an active solid tumor (cancer) or a blood‑related cancer (hematologic malignancy) that is being treated with active (non‑maintenance) therapy.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Intercommunal Creteil	Creteil	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier De Saint-Denis	St Denis	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Saint Joseph	Marseille	France
Hopital NOVO	Pontoise	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Hospital Foch	Suresnes	France
Hopital Beaujon	Clichy	France
Ccb Csemw Rhxtpgdaqcs	Lyon	France
Avrxczqgdy Pyyjunod Hskcdovm Dv Miufmutfj	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.09.2026

Trial locations

Investigated Drugs:

Azithromycin

Azithromycin is an oral antibiotic that belongs to the macrolide family. In this study it is given as a low‑dose tablet that patients have been taking for at least one year to help keep their bronchiectasis stable. The drug works by reducing inflammation and preventing bacterial infections in the lungs. The trial is testing whether stopping this medication is just as safe and effective as continuing it, so participants either keep taking azithromycin or gradually stop it under medical supervision.

Investigated Diseases:

Cystic fibrosis

Bronchiectasis, non‑cystic fibrosis – A chronic lung condition in which the large airways become permanently widened and damaged, making it hard to clear mucus. The damaged airways collect mucus, which can cause frequent coughing and recurrent infections. Over time the irritation can cause the airways to become more scarred, leading to increasing difficulty breathing. People may experience periods where symptoms suddenly get worse, known as exacerbations, followed by times of relative stability. The disease typically progresses slowly, with a gradual decline in lung capacity.

Trial ID:

2025-521493-33-00

Protocol code:

Macroleave

Trial Phase:

Therapeutic confirmatory (Phase III)

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Effect of Stopping Long‑Term Azithromycin in Stable Non‑Cystic Fibrosis Bronchiectasis Patients: A Randomized Controlled Trial

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?