Interventional, Prospective, National, Multicentre, Randomised, Open-label, Controlled Clinical Study Comparing Two Parallel Groups, One Control Arm (Standard Treatment) Versus Intervention Arm (Standard Treatment + Study Product) Evaluating the Efficacy of Respicure® 0.38% /0.38% (Resveratrol / Quercetin) Phytotherapy Product From BEKER® Laboratories as an add-on Treatment in the Management of Respiratory Conditions Including Asthma (Partially Controlled),Chronic Obstructive Pulmonary Disease "COPD" (Stage A, B, C and D) and Long Coronavirus Disease "COVID" in Algerian Adult Patients .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 402
- 试验地点
- 10
- 主要终点
- Change of COPD symptoms in patients with stage A, B, C or D.
研究概览
简要总结
Interventional, Prospective, National, Multicentre, Randomised, Open-label, Controlled Clinical Study Comparing Two Parallel Groups, One Control Arm (Standard Treatment) Versus Intervention Arm (Standard Treatment + Study Product) Evaluating the Efficacy of Respicure® 0.38% /0.38% (Resveratrol / Quercetin) Phytotherapy Product From BEKER Laboratories as an add-on Treatment in the Management of Respiratory Conditions Including Asthma (Partially Controlled),COPD (Stage A, B, C and D) and long COVID in Algerian Adult Patients .
详细描述
This is an interventional, prospective, national, multicenteric, randomized, open-label, controlled clinical study comparing two arms: Control arm taking the standard of care Versus Intervention arm (standard of care + Respicure®).
A total of 480 patients (160 in each group of pathology i.e Asthme, COPD and long COVID, distributed through 8 centers resulting in 20 patients/center for each group of pathology). The administration of the study product is by randomaisation.The data will be collected during 5 visits for the two arms as following:
- Visit V1 on D0: inclusion, signature of informed consent and implementation of the RESPIRE DZ protocol with delivery to patients of a one-month supply of Respicure® for the intervention arm,
- Intermediary visit on D15: face-to-face and/or by telephone to assess safety after the use of Respicure® for the intervention arm.
- Visit V2 on D30: follow-up visit with delivery to patients of a one-month supply of Respicure® for the intervention arm,
- Visit V3 on D60: follow-up visit with delivery to patients of a one-month supply of Respicure® for the intervention arm,
- Visit V4 at D90:follow-up visit at the end of the use of the study product,
- Visit V5 at D180: follow-up and end-of-study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for Asthma patients:
- •Male, female, aged ≥
- •Being able to provide written informed consent before the study.
- •Patient with partially controlled asthma: Assessment of asthma control over the month preceding the use of Respicure ® by a symptomatic assessment (Tick one or two symptoms):
- •3. 1 Daytime symptoms more than twice a week,
- •2 One or more nocturnal awakenings,
- •3 Need for rescue medication more than twice a week,
- •4 One or more activity limitations
- •4. Patient followed for at least a year and mastering the technique of using devices i.e. aerosols, nebulizer etc…
- •Inclusion Criteria for COPD patients:
- •Male, female, ≥40 years old
- •Being able to provide written informed consent before the study.
- •Patient with COPD stage A, B, C or D in stable condition with no exacerbations in the past 4 weeks.
- •Patient followed for at least a year and mastering the technique of using devices i.e. aerosols, nebulizer etc…
- •Inclusion Criteria for long covid patients:
- •Male, female, aged ≥
- •Being able to provide written informed consent before the study.
- •Patients followed for respiratory symptoms linked to long Covid (symptoms for more than 12 weeks).
排除标准
- •Patient with severe asthma (for asthma groupe only)
- •Prior use of Respicure®.
- •Concomitant use with the following products: cytochrome P450 3A4 substrate drugs (e.g. statin, antifungals and fexofenadine), antibiotics (quinolones), immunosuppressants (cyclosporine) and glycoprotein P substrate drugs, e.g. antifungal and antiarrhythmic .
- •Hypersensitivity to any of the ingredients.
- •Hypersensitivity to peanuts.
- •Concomitant intake of a product containing one or both of the active ingredients (resveratrol/quercetine).
- •Pregnancy/ lactation.
- •People who need to undergo surgery.
- •Participation in another clinical study within the previous 30 days.
- •Patient with asthma-COPD overlap syndrome or any other respiratory disease such as pneumonia, tuberculosis, pulmonary embolism, etc.
- •Hormone-sensitive conditions such as breast cancer, uterine cancer, ovarian cancer, endometriosis or uterine fibroids.
- •Patients requiring admission to intensive care and/or requiring respiratory assistance.
- •Patients requiring anticoagulant treatment at curative doses.
结局指标
主要结局
Change of COPD symptoms in patients with stage A, B, C or D.
时间窗: Change from Baseline at 3 months.
The assessment of reduction in symptoms will be based on reducing mMRC scoring "modified Medical Research Council" where 0 being the best and 4 being the worst.
Change of asthma symptoms in partially controlled patients .
时间窗: Change from Baseline at 3 months
The assessment of asthma management will be based on: 1\. Improvement in symptoms measured at baseline and during the follow-up period and results will be compared to those of the control group to determine asthma control using the following criteria: * Daytime symptoms at most twice a week, * No nocturnal awakenings, * Need for rescue medication at most twice a week, * No limitation of activities.
Change of respiratory symptoms related to long COVID.
时间窗: Change from Baseline at 3 months
The assessment of the respiratory symptoms linked to long COVID will be based on the reduction in dyspnea and cough by measuring m mMRC scoring "modified Medical Research Council" where 0 being the best and 4 being the worst.
次要结局
- Morbidity for Asthma patients(3 months)
- Morbidity & Exacerbations for COPD patients(6 months)
- Tolerance(3 months)
- Change of CAT scoring for Asthma patients(Change from Baseline at 3 months)
- Change of Respiratory function for COPD patients(Change from Baseline at 3 months)
- Exacerbations for COPD patients(6 months.)
- Morbidity for long COVID patients(6 months.)
- Change of Respiratory function for Asthma patients(Change from Baseline at 3 months)