AsthmaNCT05601180
Evaluation of the Efficacy of Respicure® (Resveratrol / Quercetin) in the Management of Respiratory Conditions Including Asthma,COPD and Long COVID.
A study testing Respicure® in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Beker Laboratories at 8 sites in Algeria.
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)… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease, Long COVID
- What is being tested?
- Respicure®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 8 sitesAlgeria
- Study dates
- 27 Oct 2022to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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…
- Male, female, ≥40 years old
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- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Algeria8 sites
CHU Beni Messous/Pneumologie A
Algiers
CHU Beni Messous/Pneumologie B
Algiers
CHU Annaba/Pneumo-phtisiologie
Annaba
EPH Batna/Pneumo-phtisiologie
Batna City
CHU Constantine/Pneumo-phtisiologie
Constantine
EPH Laghouat/Pneumo-phtisiologie
Laghouat
CHU Oran/Pneumo-phtisiologie B
Oran
CHU Sidi Bel Abbes/Pneumo-phtisiologie
Sidi Bel Abbes
About this study
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 .
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 .
Read the 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.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease, Long COVID
- Being tested
- Respicure®, Standard of care
- Keywords
- Phytotherapy, Inhalation, Complementary medicine
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Post-Acute COVID-19 Syndrome, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 careOther
standard treatment is prescribed by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Stadard of care | Active comparator | standard treatment that is prescribed by the treating physician. Receives: Other: Standard of care |
| Standard of care + Respicure® | Experimental | standard treatment that is prescribed by the treating physician in addition to Respicure® Receives: Other: Respicure® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of asthma symptoms in partially controlled patients .
The assessment of asthma management will be based on:
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline at 3 months
Secondary outcomes (11)
Tolerance
Tolerance to Respicure®: assessment of the occurrence of serious/non-serious adverse events during the study period.
Measured: 3 months
Morbidity for Asthma patients
Minimisation or absence of hospitalisation and Reduction of number of exacerbations
Measured: 3 months
Change of CAT scoring for Asthma patients
Improvement of CAT scoring (Asthma control test) more than 20.
Measured: Change from Baseline at 3 months
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 %)
Measured: Change from Baseline at 3 months
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 %)
Measured: Change from Baseline at 3 months
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 %)
Measured: Change from Baseline at 3 months
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",
Measured: 6 months
Exacerbations for COPD patients
The prevention of future exacerbations "time to onset of the 1st exacerbation in six (06) months",
Measured: 6 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 %)
Measured: Change from Baseline at 3 months
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 %)
Measured: Change from Baseline at 3 months
Morbidity for long COVID patients
Minimisation or absence of hospitalisation
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start27 Oct 2022
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beker Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pr Mersak GHARNAOUT, Professor, Principal investigator, CHU Beni Messous/ Pneumologie A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601180
- Sponsor's protocol ID
- RESPIRE DZ
- Status last verified
- Mar 2024
- First submitted
- 24 Oct 2022
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 .
- ClinicalTrials.gov ID
- NCT05601180
- Acronym / sponsor ID
- RESPIRE DZ
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease, Long COVID
- Keywords
- Phytotherapy, Inhalation, Complementary medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Beker LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stadard of care | Active comparator | Other: Standard of carestandard treatment that is prescribed by the treating physician. |
| Standard of care + Respicure® | Experimental | Other: Respicure®standard treatment that is prescribed by the treating physician in addition to Respicure® |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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…
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respicure®Respicure® is an inhalation solution that contains two natural extracts: quercetin and resveratrol in a concentration of 0.38%/0.38%. | Other | Standard of care + Respicure® |
| Standard of carestandard treatment is prescribed by the treating physician. | Other | Stadard of care |
Primary outcome
Change of asthma symptoms in partially controlled patients .
Time frame: Change from Baseline at 3 months
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.
Time frame: Change from Baseline at 3 months
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.
Time frame: Change from Baseline at 3 months.
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.
Time frame: Change from Baseline at 3 months
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.
Time frame: Change from Baseline at 3 months
The assessment of the respiratory symptoms linked to long COVID will be based on: - Improvement of Blood oxygen saturation.
11 secondary outcomes
Tolerance
Time frame: 3 months
Morbidity for Asthma patients
Time frame: 3 months
Change of CAT scoring for Asthma patients
Time frame: Change from Baseline at 3 months
Change of Respiratory function for Asthma patients
Time frame: Change from Baseline at 3 months
Change of Respiratory function for Asthma patients
Time frame: Change from Baseline at 3 months
Change of Respiratory function for Asthma patients
Time frame: Change from Baseline at 3 months
Morbidity & Exacerbations for COPD patients
Time frame: 6 months
Exacerbations for COPD patients
Time frame: 6 months.
Change of Respiratory function for COPD patients
Time frame: Change from Baseline at 3 months
Change of Respiratory function for COPD patients
Time frame: Change from Baseline at 3 months
Morbidity for long COVID patients
Time frame: 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pr Mersak GHARNAOUT, Professor principal investigator
CHU Beni Messous/ Pneumologie A
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respicure® in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Beker Laboratories at 8 sites in Algeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of asthma symptoms in partially controlled patients . (time frame: Change from Baseline at 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.