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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stadard of care | Active Comparator | standard treatment that is prescribed by the treating physician. |
|
| Standard of care + Respicure® | Experimental | standard treatment that is prescribed by the treating physician in addition to Respicure® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respicure® | Other | Respicure® is an inhalation solution that contains two natural extracts: quercetin and resveratrol in a concentration of 0.38%/0.38%. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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. | 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. | 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. | 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. | Change from Baseline at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance | Tolerance to Respicure®: assessment of the occurrence of serious/non-serious adverse events during the study period. | 3 months |
| Morbidity for Asthma patients | Minimisation or absence of hospitalisation and Reduction of number of exacerbations |
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Inclusion Criteria for Asthma patients:
3. 1 Daytime symptoms more than twice a week, 3. 2 One or more nocturnal awakenings, 3. 3 Need for rescue medication more than twice a week, 3. 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:
Inclusion Criteria for long covid patients:
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Pr Mersak GHARNAOUT, Professor | CHU Beni Messous/ Pneumologie A | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Beni Messous/Pneumologie A | Algiers | Algeria | ||||
| CHU Beni Messous/Pneumologie B |
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| Standard of care | Other | standard treatment is prescribed by the treating physician. |
|
| 3 months |
| Change of CAT scoring for Asthma patients | Improvement of CAT scoring (Asthma control test) more than 20. | 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 %) | 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 %) | 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 %) | 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", | 6 months |
| Exacerbations for COPD patients | The prevention of future exacerbations "time to onset of the 1st exacerbation in six (06) months", | 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 %) | 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 %) | Change from Baseline at 3 months |
| Morbidity for long COVID patients | Minimisation or absence of hospitalisation | 6 months. |
| 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 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000094024 | Post-Acute COVID-19 Syndrome |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D000094025 | Post-Infectious Disorders |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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