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

Condition studied

bronchiectasis unrelated to cystic fibrosis

Investigational medicinal product(s)

Eligibility

Primary endpoint

The primary efficacy endpoint is the annualized number of PE that have been confirmed through the event adjudication process

Endpoint detail

Time (days) to first exacerbation, Annual number of severe exacerbations, with hospitalization due to a respiratory failure, Quality-of-life score (Quality of Life-Bronchiectasis (QOL-B)16 and Bronchiectasis Impact Measure (BIM)) at inclusion, 1 year and 2 years, Emergence of macrolide-resistant strains of bacteria or mycobacteria, at inclusion, 12 and 24 months, Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC), at inclusion, 12 and 24 months, Number of days between randomization and a new prescription of preventive treatment for exacerbations (macrolides, anti-inflammatory such as brenzocatib, long-term antibiotic therapy), Prognostic factors for macrolide discontinuation failure (age, severity of the disease, Pseudomonas colonization and duration of macrolides exposition before the beginning of the trial…) will be explored by using uni- and multivariable logistic regression