Actively Recruiting
Chronic Airway Disease, Mucus Rheology and Exacerbations
Led by University Hospital, Montpellier · Updated on 2024-07-16
72
Participants Needed
3
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
R
Rheonova
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Chronic Airway Disease, Mucus Rheology and Exacerbations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 85 years
- Signed informed consent form
- Ability to attend all planned visits and comply with test procedures
- Affiliated with the French social security system
- Diagnosed with chronic obstructive pulmonary disease for at least one year according to GOLD criteria
- Receiving optimal treatment based on GOLD severity class C or D
- Experienced at least 3 exacerbations of any severity or at least 1 severe exacerbation requiring hospitalization in the past 12 months
- Able to produce spontaneous or induced sputum
- Electrocardiogram showing QTC interval less than 450 ms for men and less than 470 ms for women
- Normal hearing for age or no contraindication to long-term azithromycin according to ENT specialist
You will not qualify if you...
- Pregnant or breastfeeding
- Prisoners or under judicial protection
- Under legal guardianship
- Participation in another interventional study currently or within one month before inclusion
- Received azithromycin in the past 3 months
- Primary diagnosis of bronchial dilation confirmed by CT scan
- Known allergy to azithromycin, erythromycin, other macrolides, ketolides, or related excipients
- Taking medications that interact negatively with azithromycin (dihydroergotamine, ergotamine, cisapride, colchicine)
- Having other respiratory diseases or lung infections
- Severe liver failure or cholestasis
- Kidney impairment with creatinine clearance below 40 mL/min
- History of hematological cancer treated with allogeneic stem cell transplant
- Certain rare hereditary diseases affecting lactose metabolism due to lactose content in study medication
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
University Hospitals of Bordeaux
Bordeaux, France
Actively Recruiting
2
University Hospitals of Montpellier
Montpellier, France, 34925
Actively Recruiting
3
University Hospitals of Toulouse
Toulouse, France
Actively Recruiting
Research Team
J
Jérémy Charriot, MD
CONTACT
A
Arnaud BOURDIN, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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