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 .

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 .

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Asthma; Long COVID
• Intervention / Treatment: Other: Standard of care; Other: Respicure®

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.

• Study Type: Interventional
• Enrollment (Actual): 402
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Algeria
  • Algiers, Algeria
    • CHU Beni Messous/Pneumologie A
  • Algiers, Algeria
    • CHU Beni Messous/Pneumologie B
  • Annaba, Algeria
    • CHU Annaba/Pneumo-phtisiologie
  • Batna, Algeria
    • EPH Batna/Pneumo-phtisiologie
  • Constantine, Algeria
    • CHU Constantine/Pneumo-phtisiologie
  • Laghouat, Algeria
    • EPH Laghouat/Pneumo-phtisiologie
  • Oran, Algeria
    • CHU Oran/Pneumo-phtisiologie B
  • Sidi Bel Abbès, Algeria
    • CHU Sidi Bel Abbes/Pneumo-phtisiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• Inclusion Criteria for Asthma patients:

  1. Male, female, aged ≥19.
  2. Being able to provide written informed consent before the study.
  3. Patient with partially controlled asthma: Assessment of asthma control over the month preceding the use of Respicure ® by a symptomatic assessment (Tick one or two symptoms):

  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:

  1. Male, female, ≥40 years old
  2. Being able to provide written informed consent before the study.
  3. Patient with COPD stage A, B, C or D in stable condition with no exacerbations in the past 4 weeks.
  4. Patient followed for at least a year and mastering the technique of using devices i.e. aerosols, nebulizer etc…

• Inclusion Criteria for long covid patients:

  1. Male, female, aged ≥19.
  2. Being able to provide written informed consent before the study.
  3. Patients followed for respiratory symptoms linked to long Covid (symptoms for more than 12 weeks).

Exclusion Criteria :

1. Patient with severe asthma (for asthma groupe only)
2. Prior use of Respicure®.
3. Concomitant use with the following products: cytochrome P450 3A4 substrate drugs (e.g. statin, antifungals and fexofenadine), antibiotics (quinolones), immunosuppressants (cyclosporine) and glycoprotein P substrate drugs, e.g. antifungal and antiarrhythmic .
4. Hypersensitivity to any of the ingredients.
5. Hypersensitivity to peanuts.
6. Concomitant intake of a product containing one or both of the active ingredients (resveratrol/quercetine).
7. Pregnancy/ lactation.
8. People who need to undergo surgery.
9. Participation in another clinical study within the previous 30 days.
10. Patient with asthma-COPD overlap syndrome or any other respiratory disease such as pneumonia, tuberculosis, pulmonary embolism, etc.
11. Hormone-sensitive conditions such as breast cancer, uterine cancer, ovarian cancer, endometriosis or uterine fibroids.
12. Patients requiring admission to intensive care and/or requiring respiratory assistance.
13. Patients requiring anticoagulant treatment at curative doses.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stadard of care; standard treatment that is prescribed by the treating physician.	Other: Standard of care; standard treatment is prescribed by the treating physician.
Experimental: Standard of care + Respicure®; standard treatment that is prescribed by the treating physician in addition to Respicure®	Other: Respicure®; Respicure® is an inhalation solution that contains two natural extracts: quercetin and resveratrol in a concentration of 0.38%/0.38%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: Daytime symptoms at most twice a week,; No nocturnal awakenings,; Need for rescue medication at most twice a week,; No limitation of activities.	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Beker Laboratories
• Investigators: Principal Investigator: Pr Mersak GHARNAOUT, Professor, CHU Beni Messous/ Pneumologie A

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Inhalation; Phytotherapy; Complementary medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Hypersensitivity, Immediate; Disease Attributes; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Chronic Disease; Post-Infectious Disorders; COVID-19; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: RESPIRE DZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No