An interventional study of Respicure® and Standard of care in Asthma, Chronic Obstructive Pulmonary Disease and Long COVID, sponsored by Beker Laboratories. Completed at 8 sites in Algeria. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Beker Laboratories · Not applicable, Interventional, and Supportive care
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 .
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:
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 402 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Beker Laboratories is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Asthma patients:
Inclusion Criteria for patients:
Inclusion Criteria for long covid patients:
Exclusion Criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
standard treatment that is prescribed by the treating physician.
Other: Standard of care
standard treatment that is prescribed by the treating physician in addition to Respicure®
Other: Respicure®
Respicure® is an inhalation solution that contains two natural extracts: quercetin and resveratrol in a concentration of 0.38%/0.38%.
standard treatment is prescribed by the treating physician.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline at 3 months
Tolerance
Tolerance to Respicure®: assessment of the occurrence of serious/non-serious adverse events during the study period.
Time frame: 3 months
Morbidity for Asthma patients
Minimisation or absence of hospitalisation and Reduction of number of exacerbations
Time frame: 3 months
Change of CAT scoring for Asthma patients
Improvement of CAT scoring (Asthma control test) more than 20.
Time frame: 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 %)
Time frame: 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 %)
Time frame: 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 %)
Time frame: 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",
Time frame: 6 months
Exacerbations for COPD patients
The prevention of future exacerbations "time to onset of the 1st exacerbation in six (06) months",
Time frame: 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 %)
Time frame: 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 %)
Time frame: Change from Baseline at 3 months
Morbidity for long COVID patients
Minimisation or absence of hospitalisation
Time frame: 6 months.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beker Laboratories