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

Who is this study for? Patients with Chronic Obstructive Pulmonary Disease
What treatments are being studied? Azithropycin
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
University Hospitals of Bordeaux
RECRUITING
Bordeaux
University Hospitals of Montpellier
RECRUITING
Montpellier
University Hospitals of Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Jérémy Charriot, MD
j-charriot@chu-montpellier.fr
04 67 33 67 33
Backup
Arnaud BOURDIN, MD
a-bourdin@chu-montpellier.fr
04 67 33 67 33
Time Frame
Start Date: 2023-02-03
Estimated Completion Date: 2026-02
Participants
Target number of participants: 72
Treatments
Active_comparator: Azithromycin according to symptoms
Patients randomized to this arm will be prescribed azithromycin in function of their symptoms.
Experimental: Azithromycin according to rheology
Patients randomized to this arm will be prescribed azithromycin in function of their sputum rheology.
Sponsors
Collaborators: Rheonova
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov