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

Asthma Clinical Trial

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 .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601180
• Other study ID #: RESPIRE DZ
• Status: Completed
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: January 15, 2024

Study information

• Verified date: March 2024
• Source: Beker Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Long COVID
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Respicure®
Respicure® is an inhalation solution that contains two natural extracts: quercetin and resveratrol in a concentration of 0.38%/0.38%.
• Standard of care
standard treatment is prescribed by the treating physician.

Locations

Country	Name	City	State
Algeria	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
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 Abbès

Sponsors (1)

Lead Sponsor	Collaborator
Beker Laboratories

Country where clinical trial is conducted

Algeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.
Primary	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
Primary	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	Tolerance	Tolerance to Respicure®: assessment of the occurrence of serious/non-serious adverse events during the study period.	3 months
Secondary	Morbidity for Asthma patients	Minimisation or absence of hospitalisation and Reduction of number of exacerbations	3 months
Secondary	Change of CAT scoring for Asthma patients	Improvement of CAT scoring (Asthma control test) more than 20.	Change from Baseline at 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Exacerbations for COPD patients	The prevention of future exacerbations "time to onset of the 1st exacerbation in six (06) months",	6 months.
Secondary	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
Secondary	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
Secondary	Morbidity for long COVID patients	Minimisation or absence of hospitalisation	6 months.