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

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

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

16 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

  • Azithromycin 500 mg Film-coated Tablets

    This medication is taken by mouth as a film‑coated tablet, usually once daily. It is an approved antibiotic that is well known and studied in medical literature. It is mainly used to treat bacterial infections, especially in patients with bronchiectasis not caused by cystic fibrosis. Azithromycin works by attaching to bacterial ribosomes and stopping them from making proteins, which kills the bacteria; it belongs to the macrolide class of antibiotics.

  • Azithromycin 250 mg Film-coated Tablets

    This drug is also taken orally as a film‑coated tablet, often given once a day at a lower dose. It is a widely accepted and researched antibiotic used in many countries. It is prescribed for bacterial infections, including chronic lung disease like non‑cystic fibrosis bronchiectasis. The medicine blocks bacterial protein production by binding to ribosomes, and it is classified as a macrolide antibiotic.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521493-33-00Protocol codeMacroleaveEstimated enrolment185 patientsSponsorCentre Hospitalier Intercommunal Creteil

sourced from the EU Clinical Trials Register and site verification

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