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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-27

Study Completion Date

2024-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Breathox Device Inhalation Therapy in the Treatment of Acute Symptoms Associated With COVID-19 and in the Prevention of the Use of Health Resources

NCT05196581

COVID-19

COMPLETED PHASE2

A Study to Assess the Effectiveness and Safety of GSK3862995B in Adults With Bronchiectasis

NCT07201051

Bronchiectasis

NOT_YET_RECRUITING PHASE2

Comparison of Viral Particle Dispersion Following Administration of an MDI or Nebulizer in Subjects With COVID-19

NCT04681079

COVID-19

COMPLETED

The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis

NCT06872892

Bronchiectasis

RECRUITING PHASE3

Influence of IQPAS-119 on Post-Marathon Susceptibility to Infections and Others

NCT02873910

Upper Respiratory Tract Symptoms

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Chronic Obstructive Pulmonary Disease Long COVID

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stadard of care

standard treatment that is prescribed by the treating physician.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

standard treatment is prescribed by the treating physician.

Standard of care + Respicure®

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

Group Type EXPERIMENTAL

Respicure®

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Respicure®

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

Intervention Type OTHER

Standard of care

standard treatment is prescribed by the treating physician.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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…

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…

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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No