2024-516172-15-00招募中2 期
COPD-CARhE - Chronic Airway Disease, Mucus Rheology and Exacerbations: a Randomized Controlled Trial of COPD Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- The number of exacerbations over the 12 months of follow-up
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up
- 盲法
- Double (Investigator, Carer, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnancy or breastfeeding
- •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 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
- •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
- •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
结局指标
主要结局
The number of exacerbations over the 12 months of follow-up
The number of exacerbations over the 12 months of follow-up
次要结局
- The number of mild exacerbations throughout follow-up. A mild exacerbation does not require new additional medicine
- The number of moderate exacerbations throughout follow-up. Moderate exacerbations require antibiotics or oral corticosteroids (but not hospitalization)
- The number of severe exacerbations throughout follow-up. Severe exacerbations require hospitalization
- 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
- 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
- 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
- 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
- Comparison on sputum rheology (viscous module, parameter G'') measured using the Rheomuco device at 3 months, 6 months, 9 months and 12 months
- Comparison on sputum rheology (ratio G ''/G ') measured using the Rheomuco device at 3 months, 6 months, 9 months and 12 months
- Comparison on sputum rheology (critical constraint, parameter tau-C) measured using the Rheomuco device at 3 months, 6 months, 9 months and 12 months
- Comparison on pulmonary function (forced expiratory volume in 1 s, FEV1) measured by Spirometry at 3 months, 6 months, 9 months and 12 months
- Comparison on pulmonary function (forced vital capacity, FVC) measured by Spirometry at 3 months, 6 months, 9 months and 12 months
- Comparison on pulmonary function (FEV1/FVC ratio) measured by Spirometry at 3 months, 6 months, 9 months and 12 months
- Comparison on pulmonary function (residual volume, RV) measured by Plethysmography at baseline and 12 months
- Comparison on pulmonary function (functional residual capacity, FRC) measured by Plethysmography at baseline and 12 months
- Comparison on pulmonary function (total lung capacity, TLC) measured by Plethysmography at baseline and 12 months
- Comparison on pulmonary function (ratio RV/TLC) measured by Plethysmography at baseline and 12 months
- Comparison on drug consumption throughout follow-up
- Number of adverse events throughout follow-up
- Comparison on number of days with exacerbations and associated symptoms / treatments throughout follow-up
- Comparison on number of days of hospitalizations and associated symptoms / treatments throughout follow-up
- 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)
- 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
- 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
- Change in complete blood counts, including neutrophils, eosinophils between baseline and the end of the study
- Change in level of Serum Club cell secretory protein between baseline and the end of the study
- Comparison on number of exacerbations between the experimental and comparator arms without prescription of azithromycin
- Comparison on number of exacerbations between the experimental and comparator arms with prescription of azithromycin
- Assessment of Azithromycin prescription according to CASA-Q in the experimental arm
研究者
Jérémy CHARRIOT
Scientific
Centre Hospitalier Universitaire De Montpellier
研究点 (3)
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