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

NCT05601180 | Completed

• 1 other identifier: RESPIRE DZ
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 8

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 .

Conditions

Asthma; Chronic Obstructive Pulmonary Disease; Long COVID

Keywords

Phytotherapy; Inhalation; Complementary medicine

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (11)

• Tolerance

  3 months

• Morbidity for Asthma patients

  3 months

• Change of CAT scoring for Asthma patients

  Change from Baseline at 3 months

• Change of Respiratory function for Asthma patients

  Change from Baseline at 3 months

• Change of Respiratory function for Asthma patients

  Change from Baseline at 3 months

Study Arms (2)

Stadard of care

ACTIVE COMPARATOR

standard treatment that is prescribed by the treating physician.

Other: Standard of care

Standard of care + Respicure®

EXPERIMENTAL

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

Other: Respicure®

Interventions

Respicure® OTHER

Respicure® is an inhalation solution that contains two natural extracts: quercetin and resveratrol in a concentration of 0.38%/0.38%.

Standard of care + Respicure®

Standard of care OTHER

standard treatment is prescribed by the treating physician.

Stadard of care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• \. 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
• \. Patient followed for at least a year and mastering the technique of using devices i.e. aerosols, nebulizer etc…
• 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…
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beker Laboratories: lead

Study Sites (8)

CHU Beni Messous/Pneumologie A

Algiers, Algeria

Location

CHU Beni Messous/Pneumologie B

Algiers, Algeria

Location

CHU Annaba/Pneumo-phtisiologie

Annaba, Algeria

Location

EPH Batna/Pneumo-phtisiologie

Batna City, Algeria

Location

CHU Constantine/Pneumo-phtisiologie

Constantine, Algeria

Location

EPH Laghouat/Pneumo-phtisiologie

Laghouat, Algeria

Location

CHU Oran/Pneumo-phtisiologie B

Oran, Algeria

Location

CHU Sidi Bel Abbes/Pneumo-phtisiologie

Sidi Bel Abbes, Algeria

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Post-Acute COVID-19 Syndrome; Respiratory Aspiration

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Post-Infectious Disorders; Respiration Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Pr Mersak GHARNAOUT, Professor

  CHU Beni Messous/ Pneumologie A

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 1, 2022
• Study Start: October 27, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AL (8)