NCT04339270

Chronic Airway Disease, Mucus Rheology and Exacerbations

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The secondary objectives are to compare between the 2 arms: * exacerbation number according to their severity (observed throughout the duration of the study); * the evolution of the symptoms, the rheology of the sputum, and the pulmonary function (measurements repeated every three months); * medication consumption and adverse events (monitored throughout the duration of the study); * patient trajectories during follow-up; * the overall clinical improvement at the end of the study and the evolution of the quality of life (measurements repeated every 3 months); * the change in biomarkers of interest (baseline versus end of study).

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2023-02-03
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2020-04-09
• Last updated: 2024-07-16

Locations

3 sites across 1 country: France