COPD-CARhE - Chronic Airway Disease, Mucus Rheology and Exacerbations: a clinical Trial of COPD Patients

Prior treatment

• The patient participates in another interventional protocol, or did so in the month prior to inclusion
• Received azithromycin in the previous 3 months
• Concomitant use of medication contraindicated with azithromycin (dihydroergotamine, ergotamine, cisapride, colchicine)

Other illness

• Severe hepatic insufficiency and severe cholestasis (a liver biological test will be carried out if clinical suspicion)
• Patients with hematological malignancies who have undergone allogeneic hematopoietic stem cell transplantation
• Known hypersensitivity to azithromycin, erythromycin, any other macrolide, ketolide or any of the excipients of the azithromycin-based specialty used
• Other respiratory diseases or associated lung infections

Lab values

• Renal impairment with creatinine clearance < 40 mL/min
• Patients with conditions contraindicating the use of an azithromycinbased product due to its composition in excipient with a notable effect. For example, in the presence of lactose, patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary disease) . See the information available on the Public Drug Database, accessible on the Internet at the following address: http://base-donnees-publique.medicaments.gouv.fr

Other

• Pregnancy or breastfeeding
• Patients who are prisoners or other forms of judicial protection
• Patients under any form of tutorship / curatorship
• Patient whose primary diagnosis is bronchial dilation based on CT scan documentation

• Subjets between 40 - 85 years (included)
• 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; >=3 exacerbation (regardless of severity: mild-moderate-severe) or ≥ 1 severe exacerbations (requiring hospitalization) 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 for age or absence of contraindication to azithromycin for long course according to Oto-Rhino-Laryngological specialist opinion