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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
402
Respicure® is an inhalation solution that contains two natural extracts: quercetin and resveratrol in a concentration of 0.38%/0.38%.
standard treatment is prescribed by the treating physician.
CHU Beni Messous/Pneumologie A
Algiers, Algeria
CHU Beni Messous/Pneumologie B
Algiers, Algeria
CHU Annaba/Pneumo-phtisiologie
Annaba, Algeria
EPH Batna/Pneumo-phtisiologie
Batna City, Algeria
CHU Constantine/Pneumo-phtisiologie
Constantine, Algeria
EPH Laghouat/Pneumo-phtisiologie
Laghouat, Algeria
CHU Oran/Pneumo-phtisiologie B
Oran, Algeria
CHU Sidi Bel Abbes/Pneumo-phtisiologie
Sidi Bel Abbes, Algeria
Change of asthma symptoms in partially controlled patients .
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.
Time frame: Change from Baseline at 3 months
Change of COPD symptoms in patients with stage A, B, C or D.
The assessment of reduction in symptoms will be be compared to those of the control group and will be based on reducing CAT scoring "COPD assessment test" to be less than 10.
Time frame: Change from Baseline at 3 months
Change of COPD symptoms in patients with stage A, B, C or D.
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.
Time frame: Change from Baseline at 3 months.
Change of respiratory symptoms related to long COVID.
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.
Time frame: Change from Baseline at 3 months
Change of respiratory symptoms related to long COVID.
The assessment of the respiratory symptoms linked to long COVID will be based on: \- Improvement of Blood oxygen saturation.
Time frame: Change from Baseline at 3 months
Tolerance
Tolerance to Respicure®: assessment of the occurrence of serious/non-serious adverse events during the study period.
Time frame: 3 months
Morbidity for Asthma patients
Minimisation or absence of hospitalisation and Reduction of number of exacerbations
Time frame: 3 months
Change of CAT scoring for Asthma patients
Improvement of CAT scoring (Asthma control test) more than 20.
Time frame: Change from Baseline at 3 months
Change of Respiratory function for Asthma patients
Evaluation of respiratory function by spirometry to detect Variation of PEF (Peak expiratory flow) compared to baseline (in %)
Time frame: Change from Baseline at 3 months
Change of Respiratory function for Asthma patients
Evaluation of respiratory function by spirometry to detect: Improved FEV1/FVC ratio (Forced expiratory volume in one second/ Forced vital capacity) compared to baseline (in %)
Time frame: Change from Baseline at 3 months
Change of Respiratory function for Asthma patients
Evaluation of respiratory function by spirometry to detect a decreased FEV1 (Forced expiratory volume in one second) variability compared to baseline (in %)
Time frame: Change from Baseline at 3 months
Morbidity & Exacerbations for COPD patients
Minimisation or absence of hospitalisation and The prevention of future exacerbations "time to onset of the 1st exacerbation in six (06) months",
Time frame: 6 months
Exacerbations for COPD patients
The prevention of future exacerbations "time to onset of the 1st exacerbation in six (06) months",
Time frame: 6 months.
Change of Respiratory function for COPD patients
Evaluation of respiratory function by spirometry to detect variation of PEF (Peak expiratory flow) compared to baseline (in %)
Time frame: Change from Baseline at 3 months
Change of Respiratory function for COPD patients
Evaluation of respiratory function by spirometry to detect variation of FEV (Forced expiratory volume) compared to baseline (in %)
Time frame: Change from Baseline at 3 months
Morbidity for long COVID patients
Minimisation or absence of hospitalisation
Time frame: 6 months.
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