AZITHROMYCIN DIHYDRATE for Chronic obstructive pulmonary disease

Inclusion criteria

• {"criterion_text":"-Subjets between 40 - 85 years (included)\n-Written and signed informed consent form\n-Subjects must be able to attend all planned visits and comply with all test procedures\n-Beneficiary of or affiliated with the French social security system\n-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\n-Spontaneous or induced sputum production\n-Electrocardiogram: corrected distance between Q and T waves (QTC) <450 ms in men, QTC <470 ms in women\n-Normal audiogram for age or absence of contraindication to azithromycin for long course according to Oto-Rhino-Laryngological specialist opinion"}

Exclusion criteria

• {"criterion_text":"-Pregnancy or breastfeeding\n-Severe hepatic insufficiency and severe cholestasis (a liver biological test will be carried out if clinical suspicion)\n-Renal impairment with creatinine clearance < 40 mL/min\n-Patients with hematological malignancies who have undergone allogeneic hematopoietic stem cell transplantation\n-Patients with conditions contraindicating the use of an azithromycinbased product due to its composition in excipient with a notable effect. For example, in the presence of lactose, patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary disease) . See the information available on the Public Drug Database, accessible on the Internet at the following address: http://base-donnees-publique.medicaments.gouv.fr\n-Patients who are prisoners or other forms of judicial protection\n-Patients under any form of tutorship / curatorship\n-The patient participates in another interventional protocol, or did so in the month prior to inclusion\n-Received azithromycin in the previous 3 months\n-Patient whose primary diagnosis is bronchial dilation based on CT scan documentation\n-Known hypersensitivity to azithromycin, erythromycin, any other macrolide, ketolide or any of the excipients of the azithromycin-based specialty used\n-Concomitant use of medication contraindicated with azithromycin (dihydroergotamine, ergotamine, cisapride, colchicine)\n-Other respiratory diseases or associated lung infections"}

Primary endpoints

• {"endpoint_text":"-The number of exacerbations over the 12 months of follow-up","definition_or_measurement_approach":"-Count of exacerbations observed during the 12 months of follow-up"}

Secondary endpoints

• {"endpoint_text":"-The number of mild exacerbations throughout follow-up. A mild exacerbation does not require new additional medicine\n-The number of moderate exacerbations throughout follow-up. Moderate exacerbations require antibiotics or oral corticosteroids (but not hospitalization)\n-The number of severe exacerbations throughout follow-up. Severe exacerbations require hospitalization\n-Comparison on the evolution of symptoms assessed by the COPD Assessment Test (CAT) questionnaire score at 3 months, 6 months, 9 months and 12 months\n-Comparison on the evolution of symptoms assessed by the score of the Cough and sputum assessment questionnaire (CASA-Q) questionnaire score at 3 months, 6 months, 9 months and 12 months\n-Comparison on the evolution of symptoms assessed by the score of the Visual analogue scale (VAS) score for dyspnea, coughing and sputum production at 3 months, 6 months, 9 months and 12 months\n-Comparison on sputum rheology (modulus of elasticity of mucus, parameter G' ) measured using the Rheomuco device at 3 months, 6 months, 9 months and 12 months\n-Comparison on sputum rheology (viscous module, parameter G'') measured using the Rheomuco device at 3 months, 6 months, 9 months and 12 months\n-Comparison on sputum rheology (ratio G ''/G ') measured using the Rheomuco device at 3 months, 6 months, 9 months and 12 months\n-Comparison on sputum rheology (critical constraint, parameter tau-C) measured using the Rheomuco device at 3 months, 6 months, 9 months and 12 months\n-Comparison on pulmonary function (forced expiratory volume in 1 s, FEV1) measured by Spirometry at 3 months, 6 months, 9 months and 12 months\n-Comparison on pulmonary function (forced vital capacity, FVC) measured by Spirometry at 3 months, 6 months, 9 months and 12 months\n-Comparison on pulmonary function (FEV1/FVC ratio) measured by Spirometry at 3 months, 6 months, 9 months and 12 months\n-Comparison on pulmonary function (residual volume, RV) measured by Plethysmography at baseline and 12 months\n-Comparison on pulmonary function (functional residual capacity, FRC) measured by Plethysmography at baseline and 12 months\n-Comparison on pulmonary function (total lung capacity, TLC) measured by Plethysmography at baseline and 12 months\n-Comparison on pulmonary function (ratio RV/TLC) measured by Plethysmography at baseline and 12 months\n-Comparison on drug consumption throughout follow-up\n-Number of adverse events throughout follow-up\n-Comparison on number of days with exacerbations and associated symptoms / treatments throughout follow-up\n-Comparison on number of days of hospitalizations and associated symptoms / treatments throughout follow-up\n-Clinical improvement comparison scored via a point system from 0 to 3 at the end of the study (1 point: no more than one exacerbation without hospitalization during the 52 weeks of follow-up; 1 point: gain > 100mL in pre-bronchodilator FEV1 at the 52nd week compared to the baseline state; 1 point: variation of the CAT score during the 52 weeks of observation > 2)\n-Comparison on the evolution of quality of life by the score of the EQ-5D-5L questionnaire score at 3 months, 6 months, 9 months and 12 months\n-Comparison on the evolution of quality of life by the score of the St-George’s Respiratory questionnaire score at 3 months, 6 months, 9 months and 12 months\n-Change in complete blood counts, including neutrophils, eosinophils between baseline and the end of the study\n-Change in level of Serum Club cell secretory protein between baseline and the end of the study\n-Comparison on number of exacerbations between the experimental and comparator arms without prescription of azithromycin\n-Comparison on number of exacerbations between the experimental and comparator arms with prescription of azithromycin\n-Assessment of Azithromycin prescription according to CASA-Q in the experimental arm","definition_or_measurement_approach":"-Mild exacerbation: does not require new additional medicine\n-Moderate exacerbation: requires antibiotics or oral corticosteroids (but not hospitalization)\n-Severe exacerbation: requires hospitalization\n-Symptom evolution measured by CAT questionnaire at 3, 6, 9 and 12 months\n-Symptom evolution measured by CASA-Q at 3, 6, 9 and 12 months\n-Symptom evolution measured by VAS for dyspnea, coughing and sputum production at 3, 6, 9 and 12 months\n-Sputum rheology parameter G' measured using the Rheomuco device at 3, 6, 9 and 12 months\n-Sputum rheology parameter G'' measured using the Rheomuco device at 3, 6, 9 and 12 months\n-Sputum rheology ratio G''/G' measured using the Rheomuco device at 3, 6, 9 and 12 months\n-Sputum rheology critical constraint (tau-C) measured using the Rheomuco device at 3, 6, 9 and 12 months\n-Pulmonary function (FEV1) measured by spirometry at 3, 6, 9 and 12 months\n-Pulmonary function (FVC) measured by spirometry at 3, 6, 9 and 12 months\n-Pulmonary function (FEV1/FVC ratio) measured by spirometry at 3, 6, 9 and 12 months\n-Pulmonary function (RV) measured by plethysmography at baseline and 12 months\n-Pulmonary function (FRC) measured by plethysmography at baseline and 12 months\n-Pulmonary function (TLC) measured by plethysmography at baseline and 12 months\n-Pulmonary function (RV/TLC ratio) measured by plethysmography at baseline and 12 months\n-Drug consumption tracked throughout follow-up\n-Number of adverse events recorded throughout follow-up\n-Number of days with exacerbations and associated symptoms/treatments tracked throughout follow-up\n-Number of days of hospitalizations and associated symptoms/treatments tracked throughout follow-up\n-Clinical improvement scored 0-3 composite at end of study using specified point criteria at 52 weeks\n-Quality of life measured by EQ-5D-5L at 3, 6, 9 and 12 months\n-Quality of life measured by St George’s Respiratory Questionnaire at 3, 6, 9 and 12 months\n-Complete blood count changes between baseline and end of study\n-Serum Club cell secretory protein level change between baseline and end of study\n-Comparison of exacerbations between arms without azithromycin prescription\n-Comparison of exacerbations between arms with azithromycin prescription\n-Evaluation of azithromycin prescription according to CASA-Q in experimental arm"}

France

Earliest CTIS Part Ii Submission Date

25-07-2024

Latest Decision Or Authorization Date

04-04-2025

Processing Time Days

253

Number Of Sites

3

Number Of Participants

72

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Montpellier

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France