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

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease; MedDRA version: 21.1Level: LLTClassification code: 10010952Term: COPD Class: 10038738; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2024-516172-15-00
• Lead Sponsor: Centre Hospitalier Universitaire De Montpellier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-17
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified