Status:
RECRUITING
Chronic Airway Disease, Mucus Rheology and Exacerbations
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
Rheonova
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-85 years
Phase:
PHASE4
Brief 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 pres...
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 rhe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04339270
Start Date
February 3 2023
End Date
February 1 2026
Last Update
July 16 2024
Active Locations (3)
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1
University Hospitals of Bordeaux
Bordeaux, France
2
University Hospitals of Montpellier
Montpellier, France, 34925
3
University Hospitals of Toulouse
Toulouse, France