COPD (CHRONIC OBSTUCTIVE PULMONARY DISEASE)
Conditions
Interventions
Trade Name: AZITHROMYCIN
Product Name: AZITHROMYCIN
Pharmaceutical Form: Film-coated tablet
Sponsors
University hospital of Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: • exacerbation rates according to their severity; • changes in symptoms, mucus rheology, and lung function; • medication use and adverse events; • trajectories of patients during follow-up; • overall clinical improvement and quality of life; • 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are: • The number of exacerbations according to their severity, as well as the evolution of symptoms • The rheology of mucus • Pulmonary function • Medication consumption • Exacerbation episodes and hospitalizations, as well as associated symptoms / treatments • The clinical improvement is scored via a point system from 0 to 3. • Questionnaires SF-36, EQ-5D-5L, SGRQ (quality of life). The biomarkers of interest will be evaluated at baseline and at the end of the study: • complete blood counts, including neutrophils, eosinophils, • Serum club cell secretory protein • Bacteriology in the sputum 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 | — |
Countries
France
Contacts
Public ContactAnne CADENE
University hospital of Montpellier
Outcome results
None listed