Chronic airway disease, mucus rheology and exacerbations: a randomized controlled trial of COPD patients (COPD-CARhE)
- Conditions
- COPD (CHRONIC OBSTUCTIVE PULMONARY DISEASE)Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2019-004182-41-FR
- Lead Sponsor
- niversity hospital of Montpellier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 72
• Between 40 and 85 years old
• Signed informed consent form
• Subjects must be able to attend all scheduled visits and comply with all testing procedures
• Beneficiary of the French social security system
• Man or woman with COPD for at least 1 year defined according to the GOLD criteria and validated by the clinical investigator
• Optimal treatment according to GOLD recommendations Grade of severity C or D
• ? 1 exacerbation in the last 12 months
• Spontaneous or induced sputum production
• ECG: QTc <450 ms in man, QTc<470 ms in woman
• Normal Audiogram
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
• Pregnancy or breastfeeding
• Patients who are prisoners or other forms of judicial protection
• Patients under any form of tutorship / curatorship
• The patient participates in another interventional protocol, or did so in the month prior to inclusion
• Received azithromycin in the previous 3 months
• History of allergy or intolerance to macrolides / azithromycin
• Concomitant medication incompatible with azithromycin
• Other respiratory diseases or associated lung infections
• History of severe hepatic impairment (a liver function test will be performed if clinical suspicion)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective is to compare exacerbation rates over 12 months of follow-up between 1 group of patients with COPD treated according to standardized management (azithromycin prescribed for severe sputum) and 1 similar group in which the Azithromycin is prescribed depending on the rheology of the patient's mucus.;Secondary Objective: The secondary objectives are to compare between the 2 arms:<br>• exacerbation rates according to their severity;<br>• changes in symptoms, mucus rheology, and lung function;<br>• medication use and adverse events;<br>• trajectories of patients during follow-up;<br>• overall clinical improvement and quality of life;<br>• evolution of biomarkers of interest.;Primary end point(s): The number of exacerbations observed during the 12 month follow-up period.;Timepoint(s) of evaluation of this end point: 12 MONTHS
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary endpoints are:<br>• The number of exacerbations according to their severity, as well as the evolution of symptoms<br>• The rheology of mucus<br>• Pulmonary function<br>• Medication consumption<br>• Exacerbation episodes and hospitalizations, as well as associated symptoms / treatments<br>• The clinical improvement is scored via a point system from 0 to 3.<br>• Questionnaires SF-36, EQ-5D-5L, SGRQ (quality of life).<br>The biomarkers of interest will be evaluated at baseline and at the end of the study:<br>• complete blood counts, including neutrophils, eosinophils,<br>• Serum club cell secretory protein<br>• Bacteriology in the sputum<br>Patient safety will be ensured through a collection of adverse events throughout the duration of the study.;Timepoint(s) of evaluation of this end point: 12 MONTHS