Chronic Airway Disease, Mucus Rheology and Exacerbations (COPD-CARhE)

University Hospital Center (CHU)

Status and phase: Enrolling; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Azithropycin according to symptoms; Drug: Azithromycin according to rheology or symptoms

Study type: Interventional

Funder types: Other

Identifiers

NCT04339270

RECHMPL19_0074

Details and patient eligibility

About

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.

Full 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).

Enrollment: 72 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups

Azithromycin according to symptoms

Active Comparator group

Description:

Patients randomized to this arm will be prescribed azithromycin in function of their symptoms.

Treatment:

Drug: Azithropycin according to symptoms

Azithromycin according to rheology

Experimental group

Description:

Patients randomized to this arm will be prescribed azithromycin in function of their sputum rheology.

Treatment:

Drug: Azithromycin according to rheology or symptoms