Evaluation of the Efficacy of Respicure® (Resveratrol / Quercetin) in the Management of Respiratory Conditions Including Asthma,COPD and Long COVID.
- Conditions
- Chronic Obstructive Pulmonary DiseaseLong COVIDAsthma
- Interventions
- Other: Standard of careOther: Respicure®
- Registration Number
- NCT05601180
- Lead Sponsor
- Beker Laboratories
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 402
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stadard of care Standard of care standard treatment that is prescribed by the treating physician. Standard of care + Respicure® Respicure® standard treatment that is prescribed by the treating physician in addition to Respicure®
- Primary Outcome Measures
Name Time Method Change of COPD symptoms in patients with stage A, B, C or D. 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 . 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. Change from Baseline at 3 months The assessment of the respiratory symptoms linked to long COVID will be based on:
- Improvement of Blood oxygen saturation.
- Secondary Outcome Measures
Name Time Method Change of Respiratory function for Asthma patients Change from Baseline at 3 months Evaluation of respiratory function by spirometry to detect a decreased FEV1 (Forced expiratory volume in one second) variability compared to baseline (in %)
Morbidity for Asthma patients 3 months Minimisation or absence of hospitalisation and Reduction of number of exacerbations
Morbidity & Exacerbations for COPD patients 6 months Minimisation or absence of hospitalisation and The prevention of future exacerbations "time to onset of the 1st exacerbation in six (06) months",
Tolerance 3 months Tolerance to Respicure®: assessment of the occurrence of serious/non-serious adverse events during the study period.
Change of CAT scoring for Asthma patients Change from Baseline at 3 months Improvement of CAT scoring (Asthma control test) more than 20.
Exacerbations for COPD patients 6 months. The prevention of future exacerbations "time to onset of the 1st exacerbation in six (06) months",
Change of Respiratory function for COPD patients Change from Baseline at 3 months Evaluation of respiratory function by spirometry to detect variation of FEV (Forced expiratory volume) compared to baseline (in %)
Morbidity for long COVID patients 6 months. Minimisation or absence of hospitalisation
Trial Locations
- Locations (8)
CHU Beni Messous/Pneumologie B
🇩🇿Algiers, Algeria
CHU Annaba/Pneumo-phtisiologie
🇩🇿Annaba, Algeria
CHU Constantine/Pneumo-phtisiologie
🇩🇿Constantine, Algeria
CHU Sidi Bel Abbes/Pneumo-phtisiologie
🇩🇿Sidi Bel Abbès, Algeria
CHU Oran/Pneumo-phtisiologie B
🇩🇿Oran, Algeria
CHU Beni Messous/Pneumologie A
🇩🇿Algiers, Algeria
EPH Batna/Pneumo-phtisiologie
🇩🇿Batna, Algeria
EPH Laghouat/Pneumo-phtisiologie
🇩🇿Laghouat, Algeria