Chronic Airway Disease, Mucus Rheology and Exacerbations

• Status: Not yet recruiting
• Trial end date: 2023-05-15
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: Azithromycin

Criteria

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)