Comparing treatments for chronic obstructive pulmonary disease exacerbations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the effectiveness of azithromycin treatment based on mucus rheology compared to standardized management in patients with chronic obstructive pulmonary disease (COPD). Over a 12-month follow-up period, the study will track the number and severity of exacerbations, changes in symptoms, sputum rheology, pulmonary function, medication use, and quality of life. Participants will be monitored every three months to assess clinical improvement and changes in relevant biomarkers.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospitals of Bordeaux
  Bordeaux, France Recruiting
• University Hospitals of Montpellier
  Montpellier, France Recruiting
• University Hospitals of Toulouse
  Toulouse, France Recruiting

Study contacts

• Study coordinator: Jérémy Charriot, MD
• Email: j-charriot@chu-montpellier.fr
• Phone: 04 67 33 67 33

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.