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Impact of discontinuation of long-term macrolides in stable Non Cystic Fibrosis Bronchiectasis : a multicenter randomized controlled trial
EU CTIS ID: 2025-521493-33-00
What this study is testing
To demonstrate the non-inferiority of withdrawal of low-dose macrolides after at least 1 year of treatment, compared to its continuation, in stable NCFB patients.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥18 years of age, female or male
- Diagnosis of bronchiectasis on thoracic CT-scan
- Treatment with long-term Azithromycin for at least 12 months
- ≤ 1 pulmonary exacerbations in the last 12 months
- No severe pulmonary exacerbation (with hospitalization due to respiratory failure) in the last 12 months
- Patient affiliated with the French health care system
You likely can't join if
- Confirmed diagnosis of cystic fibrosis
- Lung transplantation
- Allogenic hematopoietic stem cell transplantation
- Women of childbearing potential * who do not accept the required contraceptive method below. Combined or progestogen-only hormonal contraception (oral, injectable, implantable, transdermal patch), Intrauterine device (IUD), including copper or hormone-releasing systems, Bilateral tubal occlusion/sterilisation, Complete sexual abstinence, only if it is the participant’s usual and preferred lifestyle and is considered reliable per protocol. * Women are considered not of childbearing potential if they are:Postmenopausal, defined as at least 12 consecutive months of spontaneous amenorrhea without an alternative medical cause, or Permanently sterilized (e.g., documented hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).
- Male participants with partners of childbearing potential who do not a accept to use appropriate contraception to prevent pregnancy during the study and for the required follow-up period will be excluded from participation; acceptable contraception methods include: - Male condom; - Vasectomy (with documented medical confirmation of surgical success); - True sexual abstinence, only if this is consistent with the participant’s usual and preferred lifestyle; Double-barrier methods (e.g., condom plus diaphragm/cervical cap/spermicide) may be used, although they are not considered highly effective methods.
- Patients who are relatives of the investigator or any member of the study team directly involved in the conduct of the study (including physicians, pharmacists, nurses, and study coordinators).
See the full eligibility criteria
Who can join
- ≥18 years of age, female or male
- Diagnosis of bronchiectasis on thoracic CT-scan
- Treatment with long-term Azithromycin for at least 12 months
- ≤ 1 pulmonary exacerbations in the last 12 months
- No severe pulmonary exacerbation (with hospitalization due to respiratory failure) in the last 12 months
- Patient affiliated with the French health care system
- Able to understand and sign a written informed consent form
What rules you out
- Confirmed diagnosis of cystic fibrosis
- Lung transplantation
- Allogenic hematopoietic stem cell transplantation
- Women of childbearing potential * who do not accept the required contraceptive method below. Combined or progestogen-only hormonal contraception (oral, injectable, implantable, transdermal patch), Intrauterine device (IUD), including copper or hormone-releasing systems, Bilateral tubal occlusion/sterilisation, Complete sexual abstinence, only if it is the participant’s usual and preferred lifestyle and is considered reliable per protocol. * Women are considered not of childbearing potential if they are:Postmenopausal, defined as at least 12 consecutive months of spontaneous amenorrhea without an alternative medical cause, or Permanently sterilized (e.g., documented hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).
- Male participants with partners of childbearing potential who do not a accept to use appropriate contraception to prevent pregnancy during the study and for the required follow-up period will be excluded from participation; acceptable contraception methods include: - Male condom; - Vasectomy (with documented medical confirmation of surgical success); - True sexual abstinence, only if this is consistent with the participant’s usual and preferred lifestyle; Double-barrier methods (e.g., condom plus diaphragm/cervical cap/spermicide) may be used, although they are not considered highly effective methods.
- Patients who are relatives of the investigator or any member of the study team directly involved in the conduct of the study (including physicians, pharmacists, nurses, and study coordinators).
- Patients deprived of liberty by administrative or judicial decision.
- Patients under legal protection (guardianship or legal supervision).
- A primary diagnosis of COPD or asthma as judged by the Investigator. Patients with comorbid COPD and/or asthma can be enrolled if bronchiectasis is their primary diagnosis.
- Pregnancy or breastfeeding
- Patient participating to another interventional clinical trial
- Predictable monitoring issues
- Long-term oxygen therapy and/or noninvasive mechanical ventilation for chronic respiratory insufficiency (except CPAP for OSA) and/or FEV1<30% of predicted value and/or and/or considered for lung transplantation
- Contraindication to the use of azithromycin: -allergy to macrolides or ketolides - hypersensitivity to any of the excipients - concomitant treatment with QT-interval–prolonging agents; - electrolyte disturbances (hypokalaemia, hypomagnesaemia); - clinically significant bradycardia, cardiac arrhythmia, or severe heart failure; - renal impairment with creatinine clearance < 40 mL/min - - co-administration with alcaloides de l’ergot de seigle (dihydroergotamine, ergotamin), cisapride and ; colchicine - - QTc is >450 ms for men and >470 ms for women - - Severe liver impairment
- Severe hemoptysis due to a respiratory cause
- Patient with a solid tumor or hematologic malignancy receiving active (non-maintenance) treatment.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.