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

Centre Hospitalier Universitaire De Montpellier0 个研究点目标入组 72 人开始时间: 2024年7月17日最近更新: 2024年8月21日

适应症

试验速览

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•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

•Pregnancy or breastfeeding, Severe hepatic insufficiency and severe cholestasis (a liver biological test will be carried out if clinical suspicion), Renal impairment with creatinine clearance < 40 mL/min, Patients with hematological malignancies who have undergone allogeneic hematopoietic stem cell transplantation, 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, Patients who are prisoners or other forms of judicial protection, Patients under any form of tutorship / curatorship, The patient participates in another interventional protocol, or did so in the month prior to inclusion, Received azithromycin in the previous 3 months, Patient whose primary diagnosis is bronchial dilation based on CT scan documentation, Known hypersensitivity to azithromycin, erythromycin, any other macrolide, ketolide or any of the excipients of the azithromycin-based specialty used, Concomitant use of medication contraindicated with azithromycin (dihydroergotamine, ergotamine, cisapride, colchicine), Other respiratory diseases or associated lung infections

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