NCT05601180

Evaluation of the Efficacy of Respicure® (Resveratrol / Quercetin) in the Management of Respiratory Conditions Including Asthma,COPD and Long COVID.

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 .

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: Beker Laboratories · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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 .

Detailed description

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.

Conditions

• Asthma
• Chronic Obstructive Pulmonary Disease
• Long COVID

Interventions

Type	Name	Description
OTHER	Respicure®	Respicure® is an inhalation solution that contains two natural extracts: quercetin and resveratrol in a concentration of 0.38%/0.38%.
OTHER	Standard of care	standard treatment is prescribed by the treating physician.

Timeline

• Start date: 2022-10-27
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2022-11-01
• Last updated: 2024-03-19

Locations

8 sites across 1 country: Algeria