RecruitingPhase 4NCT04339270

Chronic Airway Disease, Mucus Rheology and Exacerbations

Chronic Airway Disease, Mucus Rheology and Exacerbations: a Randomized Controlled Trial of COPD Patients

Sponsor

University Hospital, Montpellier

Enrollment

72 participants

Start Date

Feb 3, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Obstructive Pulmonary Disease

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

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how the thickness and stickiness of mucus in the airways relates to how often people with severe COPD (chronic obstructive pulmonary disease) have flare-ups (exacerbations). Researchers are also testing whether treatments that target mucus can reduce these flare-ups. **You may be eligible if...** - You are between 40 and 85 years old - You have had a confirmed COPD diagnosis for at least 1 year - Your COPD is classified as severe (GOLD category C or D) and optimally treated - You have had 3 or more COPD flare-ups in the past year, or at least 1 requiring hospitalization - You are able to produce sputum (mucus) spontaneously or with assistance - Your heart rhythm test (ECG) and hearing are within acceptable ranges **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are currently participating in another interventional trial - You have a condition that makes the study drug (azithromycin) unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzithropycin 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.

DRUGAzithromycin 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.

Locations(3)

University Hospitals of Bordeaux

Bordeaux, France

University Hospitals of Montpellier

Montpellier, France

University Hospitals of Toulouse

Toulouse, France

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NCT04339270

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