Clinical trial NCT05601180: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Long COVID
Keywords: Phytotherapy
Inhalation
Complementary medicine
Lead sponsor: Beker Laboratories
Sponsor class: INDUSTRY
First posted: 2022-11-01
Enrollment: 402
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Change of asthma symptoms in partially controlled patients .
timeFrame: Change from Baseline at 3 months
measure: Change of COPD symptoms in patients with stage A, B, C or D.
timeFrame: Change from Baseline at 3 months
measure: Change of COPD symptoms in patients with stage A, B, C or D.
timeFrame: Change from Baseline at 3 months.
measure: Change of respiratory symptoms related to long COVID.
timeFrame: Change from Baseline at 3 months
measure: Change of respiratory symptoms related to long COVID.
timeFrame: Change from Baseline at 3 months
Secondary outcomes:
measure: Tolerance
timeFrame: 3 months
measure: Morbidity for Asthma patients
timeFrame: 3 months
measure: Change of CAT scoring for Asthma patients
timeFrame: Change from Baseline at 3 months
measure: Change of Respiratory function for Asthma patients
timeFrame: Change from Baseline at 3 months
measure: Change of Respiratory function for Asthma patients
timeFrame: Change from Baseline at 3 months
measure: Change of Respiratory function for Asthma patients
timeFrame: Change from Baseline at 3 months
measure: Morbidity & Exacerbations for COPD patients
timeFrame: 6 months
measure: Exacerbations for COPD patients
timeFrame: 6 months.
measure: Change of Respiratory function for COPD patients
timeFrame: Change from Baseline at 3 months
measure: Change of Respiratory function for COPD patients
timeFrame: Change from Baseline at 3 months
measure: Morbidity for long COVID patients
timeFrame: 6 months.
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: CHU Beni Messous/Pneumologie A
city: Algiers
country: Algeria
facility: CHU Beni Messous/Pneumologie B
city: Annaba
country: Algeria
facility: CHU Annaba/Pneumo-phtisiologie
city: Batna
country: Algeria
facility: EPH Batna/Pneumo-phtisiologie
city: Constantine
country: Algeria
facility: CHU Constantine/Pneumo-phtisiologie
city: Laghouat
country: Algeria
facility: EPH Laghouat/Pneumo-phtisiologie
city: Oran
country: Algeria
facility: CHU Oran/Pneumo-phtisiologie B
city: Sidi Bel Abbès
country: Algeria
facility: CHU Sidi Bel Abbes/Pneumo-phtisiologie
Study officials:
affiliation: CHU Beni Messous/ Pneumologie A
name: Pr Mersak GHARNAOUT, Professor
role: PRINCIPAL_INVESTIGATOR
References: