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COPD-CARhE - Chronic Airway Disease, Mucus Rheology and Exacerbations: a clinical Trial of COPD Patients
EU CTIS ID: 2024-516172-15-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.