Tests how azithromycin is chosen to prevent flare-ups in COPD
Compares two ways of choosing azithromycin in adults with COPD.
Plain-language title generated from the registry record
Registry title: COPD-CARhE - Chronic Airway Disease, Mucus Rheology and Exacerbations: a clinical Trial of COPD Patients
Key facts
- Where
- Montpellier Cedex 5, Pessac, and Toulouse, FranceSee the 3 sites
- Phase
- Phase 2
Where in France
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- Centre Hospitalier Universitaire de BordeauxPessac, FranceTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire De Montpellier
- Trial code
- NCT04669270EU 2024-516172-15-00
- Record updated
- 4 April 2025
- Original description
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.Read full original descriptionShow less
COPD-CARhE - Chronic Airway Disease, Mucus Rheology and Exacerbations: a Randomized Controlled Trial of COPD Patients
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.
Inclusion: 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: 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); 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; 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; 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.