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Clinical Trials in France / NCT04339270
Recruiting Phase 4

Chronic Airway Disease, Mucus Rheology and Exacerbations

NCT04339270 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Montpellier
Phase
Phase 4
Started
2023-02-03
Last updated
2026-09-24

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

Azithropycin according to symptomsAzithromycin according to rheology or symptoms

Azithropycin according to symptoms: Patients randomized to the "standardized comparator arm" will benefit from the standard treatment for COPD, including with regard to the prescription of azithromycin in case of severe sputum complaints (here defined by a CASA-Q sputum symptoms score \<70 to homogenize practices between centers). CASA-Q will be evaluated every 3 months. * If the patient has a sputum symptoms score \<70, a prescription for 3 months of azithromycin treatment will be initiated. This prescription can be renewed every 3 months during the 12 months of follow-up planned in this study, if the patient continues to obtain a sputum symptoms score \<70. * If the patient has a sputum symptoms score\> 70, management is not changed.

Azithromycin according to rheology or symptoms: Treatment according to standard COPD management, except for the prescription of azithromycin, which will be prescribed in function of mucus rheology or as a function of sputum complaints (here defined by a CASA-Q sputum symptoms score \<70). The rheology of mucus will be quantified every 3 months. * If the patient has spontaneous or induced sputum, and this sputum has a critical constraint (tau-C) \> 39, a prescription for 3 months of azithromycin treatment will be initiated. This prescription may be renewed every 3 months during the 12 months of follow-up planned in this study. * If the patient has a sputum symptoms score \<70, a prescription for 3 months of azithromycin treatment will be initiated. This prescription can be renewed every 3 months during the 12 months of follow-up planned in this study, if the patient continues to obtain a sputum symptoms score \<70. * If the patient has a sputum symptoms score\> 70, management is not changed.

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The main outcome measure is the number of exacerbations over the 12 months of follow-up. — 12 months
    An exacerbation is defined according to French recommendations as an "acute event characterized by worsening of respiratory symptoms (notably cough, sputum and dyspnea) beyond \[normal\] daily variation and leading to a modification of treatment: either a simple increase in bronchodilators (in this case, a duration greater than 24 hours is required to define an exacerbation) or the addition of another treatment (antibiotic therapy and / or oral corticosteroid therapy)."

Trial sites (3)

FacilityCityRegionStatus
University Hospitals of Bordeaux Bordeaux France Recruiting
University Hospitals of Montpellier Montpellier France Recruiting
University Hospitals of Toulouse Toulouse France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04339270 on ClinicalTrials.gov ↗ ← All trials in France