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Chronic Airway Disease, Mucus Rheology and Exacerbations

Study acronym: COPD-CARhE
StatusRecruiting
PhasePhase 4
Started2023-02-03
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Feb 2026 → Feb 2027
See other at-risk trials from University Hospital, Montpellier

Amendment history

2026-09-25
Trial status changed: Unknown → Recruiting
Primary completion pushed: 2026-02 → 2027-02
Completion pushed: 2026-02 → 2027-02
2026-08-02
Trial status changed: Recruiting → Unknown
2024-07-15
Recruiting→Unknown Study Status, Contacts/Locations v5
Trial statusRecruiting→Unknown
Study sitesdetails revised at 1 of 3 sites
2023-07-13
Study Status, Study Description, Eligibility v4
Eligibility criteria+231 characters
[...] 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 product [...] (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 [...]
Study description+1 characters
The secondary objectives are to compare between the 2 arms: exacerbation ratesnumber according to their severity (observed throughout the durati [...]
2023-02-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-09→2026-02
Completion date2025-09→2026-02
Start dateestimated 2022-09→confirmed 2023-02-03
Study sitesdetails revised at 3 of 3 sites
Show 2 earlier versions
2022-05-25
Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v2
Primary completion date2024-05-15→2025-09
Completion date2024-05-15→2025-09
Start date2022-02→2022-09
InterventionsAzithromycin according to rheology (Drug), Azithropycin according to symptoms (Drug)→Azithromycin according to rheology or symptoms (Drug), Azithropycin according to symptoms (Drug)
Eligibility criteria+579 characters
Inclusion Criteria: Subjets between 40 - 85 years (included) Written and signed informed consent form Subjects must be ab [...] ent according to GOLD class severity C or D recommendations 1>=3 exacerbation in the past 12 months Spontaneous or induced s [...] eding inclusion) Received azithromycin in the past 3 months HistoryPatient whose primary diagnosis is bronchial dilation based on CT scan documentation Known hypersensitivity to azithromycin, erythromycin, any other macrolide, ketolide or any of allergythe orexcipients intoleranceof to macrolides /the azithromycin-based specialty used Concomitant use of [...] [...]
Study sitescontacts updated at 1 of 3 sites
Collaborators+8 characters
Rheonova
2021-12-20
Study Status v1
Primary completion date2023-05-15→2024-05-15
Completion date2023-05-15→2024-05-15
Start date2020-05-15→2022-02
2020-04-05
Original filing
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.
Trial Details
NCT Number NCT04339270
Lead Sponsor University Hospital, Montpellier
Collaborators: Rheonova
Conditions Chronic Obstructive Pulmonary Disease
Enrollment 72 participants
Start Date 2023-02-03
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-24