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

Conditions

bronchiectasis unrelated to cystic fibrosis

Brief summary

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

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGAzithromycin 500 mg Film-coated Tablets

DRUGAzithromycin 250 mg Film-coated Tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Outcome results

None listed