Comparing treatments for chronic obstructive pulmonary disease exacerbations
Chronic Airway Disease, Mucus Rheology and Exacerbations: a Randomized Controlled Trial of COPD Patients
This study is testing if a specific antibiotic treatment can help people with COPD have fewer flare-ups and feel better compared to standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 3 sites (Bordeaux and 2 other locations) |
| Trial ID | NCT04339270 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-85 with a diagnosis of COPD who have experienced multiple exacerbations in the past year.
Not a fit: Patients with stable COPD who have not had recent exacerbations or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for managing COPD exacerbations.
How similar studies have performed: Other studies have explored similar treatment approaches, but this specific methodology focusing on mucus rheology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bordeaux and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.