Impact of discontinuation of long-term macrolides in stable Non Cystic Fibrosis Bronchiectasis : a multicenter randomized controlled trial

Trial details

Who runs it

Centre Hospitalier Intercommunal Creteil

Trial code

EU 2025-521493-33-00

Record updated

2026. július 6.

Original description

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.Read full original descriptionShow less

Macroleave: Impact of discontinuation of long-term macrolides in stable Non Cystic Fibrosis Bronchiectasis : a multicenter randomized controlled trial

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.

Inclusion: ≥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.

Exclusion: Lung transplantation; Allogenic hematopoietic stem cell transplantation; 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; Patient with a solid tumor or hematologic malignancy receiving active (non-maintenance) treatment; 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; Confirmed diagnosis of cystic fibrosis; 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); 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; Severe hemoptysis due to a respiratory cause.

EU CTIS 2025-521493-33-00