Overview
The main objective of this trial is to compare the exacerbation number over 12 months of follow-up between a group of patients with COPD treated according to standardized management (azithromycin prescribed in the event of severe sputum according to the CASA-Q score , standardized comparator arm) and a similar group in which azithromycin is prescribed based on mucus rheology (experimental arm) or CASA-Q.
Description
The secondary objectives are to compare between the 2 arms:
- exacerbation number 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).
Eligibility
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
- 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
- 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
- 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 galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary disease) due to the presence of lactose in the specialty Zithromax.