Chronic Airway Disease, Mucus Rheology and Exacerbations
Chronic Airway Disease, Mucus Rheology and Exacerbations
The main objective of this trial is to compare the exacerbation rates over 12 months of
 follow-up between a group of patients with COPD treated according to standardized management
 (standardized comparator arm: azithromycin prescribed in case of severe sputum according to
 the CASA-Q score) and a similar group in which azithromycin is prescribed according to mucus
 rheology (experimental arm).
The secondary objectives are to compare between the 2 arms:

 -  exacerbation rates according to their severity (observed throughout the duration of the
 study);

 -  the evolution of the symptoms, the rheology of the sputum, and the pulmonary function
 (measurements repeated every three months);

 -  medication consumption and adverse events (monitored throughout the duration of the
 study);

 -  patient trajectories during follow-up;

 -  the overall clinical improvement at the end of the study and the evolution of the
 quality of life (measurements repeated every 3 months);

 -  the change in biomarkers of interest (baseline versus end of study).
Inclusion Criteria:

 -  Written and signed informed consent form

 -  Subjects must be able to attend all planned visits and comply with all test procedures

 -  Beneficiary of or affiliated with the French social security system

 -  Man or woman with chronic obstructive pulmonary disease for at least 1 year defined
 according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
 and validated by the clinical investigator

 -  Optimal treatment according to GOLD class severity C or D recommendations

 -  1 exacerbation in the past 12 months

 -  Spontaneous or induced sputum production

 -  Electrocardiogram: corrected distance between Q and T waves (QTC) <450 ms in men, QTC
 <470 ms in women

 -  Normal audiogram

 Exclusion Criteria:

 -  Pregnancy or breastfeeding

 -  Patients who are prisoners or under other forms of judicial protection

 -  Patients under any form of guardianship

 -  Participation in another interventional protocol, (current or during the month
 preceding inclusion)

 -  Received azithromycin in the past 3 months

 -  History of allergy or intolerance to macrolides / azithromycin

 -  Concomitant use of medication contraindicated with azithromycin (dihydroergotamine,
 ergotamine, cisapride, colchicine)

 -  Other respiratory diseases or associated lung infections

 -  Known history of severe hepatic impairment (a liver function test will be performed in
 case of clinical suspicion)