NCT04339270RecruitingPhase 4
Chronic Airway Disease, Mucus Rheology and Exacerbations
Chronic Airway Disease, Mucus Rheology and Exacerbations: a Randomized Controlled Trial of COPD Patients
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 2 Apr 2020
- Start date
- 3 Feb 2023
- Primary completion date
- Feb 2027
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- COPD
- NCT number
- NCT04339270
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 72
- From 3 Feb 2023 to the primary completion date, Feb 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received azithromycin in the past 3 months
- Concomitant use of medication contraindicated with azithromycin (dihydroergotamine, ergotamine, cisapride, colchicine)
Other illness
- Known hypersensitivity to azithromycin, erythromycin, any other macrolide, ketolide or any of the excipients of the azithromycin-based specialty used
- Other respiratory diseases or associated lung infections
- Severe hepatic insufficiency and severe cholestasis (a liver biological test will be carried out if clinical suspicion)
- Patients with hematological malignancies who have undergone allogeneic hematopoietic stem cell transplantation
Lab values
- Renal impairment with creatinine clearance \< 40 mL/min
- 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.
Other
- 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)
- Patient whose primary diagnosis is bronchial dilation based on CT scan documentation
Who the study is looking for
- 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
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals of Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| University Hospitals of Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| University Hospitals of Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.