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

Primary Purpose

Asthma, Chronic Obstructive Pulmonary Disease, Long COVID

Status
Recruiting
Phase
Not Applicable
Locations
Algeria
Study Type
Interventional
Intervention
Respicure®
Standard of care
Sponsored by
Beker Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Phytotherapy, Inhalation, Complementary medicine

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for Asthma patients: Male, female, aged ≥19. Being able to provide written informed consent before the study. 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: Male, female, ≥40 years old Being able to provide written informed consent before the study. Patient with COPD stage A, B, C or D in stable condition with no exacerbations in the past 4 weeks. 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: Male, female, aged ≥19. Being able to provide written informed consent before the study. Patients followed for respiratory symptoms linked to long Covid (symptoms for more than 12 weeks). Exclusion Criteria : Patient with severe asthma (for asthma groupe only) Prior use of Respicure®. 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 . Hypersensitivity to any of the ingredients. Hypersensitivity to peanuts. Concomitant intake of a product containing one or both of the active ingredients (resveratrol/quercetine). Pregnancy/ lactation. People who need to undergo surgery. Participation in another clinical study within the previous 30 days. Patient with asthma-COPD overlap syndrome or any other respiratory disease such as pneumonia, tuberculosis, pulmonary embolism, etc. Hormone-sensitive conditions such as breast cancer, uterine cancer, ovarian cancer, endometriosis or uterine fibroids. Patients requiring admission to intensive care and/or requiring respiratory assistance. Patients requiring anticoagulant treatment at curative doses.

Sites / Locations

  • CHU Beni Messous/Pneumologie ARecruiting
  • CHU Beni Messous/Pneumologie BRecruiting
  • CHU Annaba/Pneumo-phtisiologie
  • EPH Batna/Pneumo-phtisiologie
  • CHU Constantine/Pneumo-phtisiologieRecruiting
  • EPH Laghouat/Pneumo-phtisiologieRecruiting
  • CHU Oran/Pneumo-phtisiologie B
  • CHU Sidi Bel Abbes/Pneumo-phtisiologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Stadard of care

Standard of care + Respicure®

Arm Description

standard treatment that is prescribed by the treating physician.

standard treatment that is prescribed by the treating physician in addition to Respicure®

Outcomes

Primary Outcome Measures

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 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 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 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 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.

Secondary Outcome Measures

Tolerance
Tolerance to Respicure®: assessment of the occurrence of serious/non-serious adverse events during the study period.
Morbidity for Asthma patients
Minimisation or absence of hospitalisation and Reduction of number of exacerbations
Change of CAT scoring for Asthma patients
Improvement of CAT scoring (Asthma control test) more than 20.
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 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 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 %)
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",
Exacerbations for COPD patients
The prevention of future exacerbations "time to onset of the 1st exacerbation in six (06) 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 of Respiratory function for COPD patients
Evaluation of respiratory function by spirometry to detect variation of FEV (Forced expiratory volume) compared to baseline (in %)
Morbidity for long COVID patients
Minimisation or absence of hospitalisation

Full Information

First Posted
October 24, 2022
Last Updated
July 27, 2023
Sponsor
Beker Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT05601180
Brief Title
Evaluation of the Efficacy of Respicure® (Resveratrol / Quercetin) in the Management of Respiratory Conditions Including Asthma,COPD and Long COVID.
Official Title
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 .
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beker Laboratories

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic Obstructive Pulmonary Disease, Long COVID
Keywords
Phytotherapy, Inhalation, Complementary medicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stadard of care
Arm Type
Active Comparator
Arm Description
standard treatment that is prescribed by the treating physician.
Arm Title
Standard of care + Respicure®
Arm Type
Experimental
Arm Description
standard treatment that is prescribed by the treating physician in addition to Respicure®
Intervention Type
Other
Intervention Name(s)
Respicure®
Intervention Description
Respicure® is an inhalation solution that contains two natural extracts: quercetin and resveratrol in a concentration of 0.38%/0.38%.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
standard treatment is prescribed by the treating physician.
Primary Outcome Measure Information:
Title
Change of asthma symptoms in partially controlled patients .
Description
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
Title
Change of COPD symptoms in patients with stage A, B, C or D.
Description
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
Title
Change of COPD symptoms in patients with stage A, B, C or D.
Description
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.
Title
Change of respiratory symptoms related to long COVID.
Description
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
Title
Change of respiratory symptoms related to long COVID.
Description
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
Secondary Outcome Measure Information:
Title
Tolerance
Description
Tolerance to Respicure®: assessment of the occurrence of serious/non-serious adverse events during the study period.
Time Frame
3 months
Title
Morbidity for Asthma patients
Description
Minimisation or absence of hospitalisation and Reduction of number of exacerbations
Time Frame
3 months
Title
Change of CAT scoring for Asthma patients
Description
Improvement of CAT scoring (Asthma control test) more than 20.
Time Frame
Change from Baseline at 3 months
Title
Change of Respiratory function for Asthma patients
Description
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
Title
Change of Respiratory function for Asthma patients
Description
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
Title
Change of Respiratory function for Asthma patients
Description
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
Title
Morbidity & Exacerbations for COPD patients
Description
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
Title
Exacerbations for COPD patients
Description
The prevention of future exacerbations "time to onset of the 1st exacerbation in six (06) months",
Time Frame
6 months.
Title
Change of Respiratory function for COPD patients
Description
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
Title
Change of Respiratory function for COPD patients
Description
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
Title
Morbidity for long COVID patients
Description
Minimisation or absence of hospitalisation
Time Frame
6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Asthma patients: Male, female, aged ≥19. Being able to provide written informed consent before the study. 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: Male, female, ≥40 years old Being able to provide written informed consent before the study. Patient with COPD stage A, B, C or D in stable condition with no exacerbations in the past 4 weeks. 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: Male, female, aged ≥19. Being able to provide written informed consent before the study. Patients followed for respiratory symptoms linked to long Covid (symptoms for more than 12 weeks). Exclusion Criteria : Patient with severe asthma (for asthma groupe only) Prior use of Respicure®. 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 . Hypersensitivity to any of the ingredients. Hypersensitivity to peanuts. Concomitant intake of a product containing one or both of the active ingredients (resveratrol/quercetine). Pregnancy/ lactation. People who need to undergo surgery. Participation in another clinical study within the previous 30 days. Patient with asthma-COPD overlap syndrome or any other respiratory disease such as pneumonia, tuberculosis, pulmonary embolism, etc. Hormone-sensitive conditions such as breast cancer, uterine cancer, ovarian cancer, endometriosis or uterine fibroids. Patients requiring admission to intensive care and/or requiring respiratory assistance. Patients requiring anticoagulant treatment at curative doses.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahlem Sarah Moulay Brahim
Phone
00560802479
Email
dr.pharmacienne@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meriem Aouchar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pr Mersak GHARNAOUT, Professor
Organizational Affiliation
CHU Beni Messous/ Pneumologie A
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Beni Messous/Pneumologie A
City
Algiers
Country
Algeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof.Mersak GHARNAOUT, Professor
First Name & Middle Initial & Last Name & Degree
Prof.Mersak GHARNAOUT, Professor
Facility Name
CHU Beni Messous/Pneumologie B
City
Algiers
Country
Algeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof.Rachida KHELAFI, Professor
First Name & Middle Initial & Last Name & Degree
Prof.Rachida KHELAFI, Professor
Facility Name
CHU Annaba/Pneumo-phtisiologie
City
Annaba
Country
Algeria
Individual Site Status
Completed
Facility Name
EPH Batna/Pneumo-phtisiologie
City
Batna
Country
Algeria
Individual Site Status
Completed
Facility Name
CHU Constantine/Pneumo-phtisiologie
City
Constantine
Country
Algeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Zinelabidine MOKRANE, Professor
First Name & Middle Initial & Last Name & Degree
Prof. Zinelabidine MOKRANE, Professor
Facility Name
EPH Laghouat/Pneumo-phtisiologie
City
Laghouat
Country
Algeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr.Redouane BENAZZOUZ, Doctor
First Name & Middle Initial & Last Name & Degree
Dr.Redouane BENAZZOUZ, Doctor
Facility Name
CHU Oran/Pneumo-phtisiologie B
City
Oran
Country
Algeria
Individual Site Status
Completed
Facility Name
CHU Sidi Bel Abbes/Pneumo-phtisiologie
City
Sidi Bel Abbès
Country
Algeria
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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