Asthma Clinical Trial
Official title:
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 .
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 .
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. ;
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