Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Chronic Airway Disease, Mucus Rheology and Exacerbations

Chronic Airway Disease, Mucus Rheology and Exacerbations: a Randomized Controlled Trial of COPD Patients

Chronic Airway Disease, Mucus Rheology and Exacerbations (NCT04339270) is a Phase 4 interventional studying Chronic Obstructive Pulmonary Disease, sponsored by University Hospital, Montpellier. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 72 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Chronic Obstructive Pulmonary Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Subjets between 40 - 85 years (included) - Written and signed willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Azithropycin according to symptoms

Patients randomized to the "standardized comparator arm" will benefit from the standard treatment for COPD, including with regard to the prescription of azithromycin in case of severe sputum complaints (here defined by a CASA-Q sputum symptoms score \<70 to homogenize practices between centers). CASA-Q will be evaluated every 3 months. * If the patient has a sputum symptoms score \<70, a prescription for 3 months of azithromycin treatment will be initiated. This prescription can be renewed every 3 months during the 12 months of follow-up planned in this study, if the patient continues to obtain a sputum symptoms score \<70. * If the patient has a sputum symptoms score\> 70, management is not changed.

DRUG

Azithromycin according to rheology or symptoms

Treatment according to standard COPD management, except for the prescription of azithromycin, which will be prescribed in function of mucus rheology or as a function of sputum complaints (here defined by a CASA-Q sputum symptoms score \<70). The rheology of mucus will be quantified every 3 months. * If the patient has spontaneous or induced sputum, and this sputum has a critical constraint (tau-C) \> 39, a prescription for 3 months of azithromycin treatment will be initiated. This prescription may be renewed every 3 months during the 12 months of follow-up planned in this study. * If the patient has a sputum symptoms score \<70, a prescription for 3 months of azithromycin treatment will be initiated. This prescription can be renewed every 3 months during the 12 months of follow-up planned in this study, if the patient continues to obtain a sputum symptoms score \<70. * If the patient has a sputum symptoms score\> 70, management is not changed.

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University Hospitals of Bordeaux

Bordeaux, France

University Hospitals of Montpellier

Montpellier, France

University Hospitals of Toulouse

Toulouse, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04339270), the sponsor (University Hospital, Montpellier), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04339270 clinical trial studying?

Who can participate in NCT04339270?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04339270?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT04339270. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04339270. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.