Chronic Airway Disease, Mucus Rheology and Exacerbations
Chronic Airway Disease, Mucus Rheology and Exacerbations: a Randomized Controlled Trial of COPD Patients
- Chronic Obstructive Pulmonary Disease
At a glance
- Phase
- Phase 4
- Study type
- Interventional
- Sponsor
- University Hospital, Montpellier
- Enrolment target
- 72
- Started
- 3 February 2023
- Main results due
- February 2027
- Study sites
- 3
- Registry updated
- 24 September 2026
Can you take part?
- Ages 40 years to 85 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(3)
University Hospitals of Bordeaux
Bordeaux, France
Recruiting
University Hospitals of Montpellier
Montpellier, France
Recruiting
University Hospitals of Toulouse
Toulouse, France
Recruiting
Showing 3 of 3 sites. 3 of the 3 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT04339270. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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