Allergic RhinitisPhase 4RENIMNCT03349619
Nebulized Resveratrol Plus Carboxymethyl-β-Glucan for Reducing IL-5 in Children With Allergic Rhinitis
A Phase 4 study testing Resveratrol plus Carboxymethyl-β-Glucan in people with Allergic Rhinitis, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
Single-center, randomized, placebo-controlled study to: characterize the subjects at baseline and discriminate groups of children based on IL-5, IL-17, IL-23 and INF-γ; investigate the effect of Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) for nostril three times/day for 4 weeks, in comparison… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Resveratrol plus Carboxymethyl-β-Glucan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- 5 Mar 2018to 31 Jul 2018
- Phase
- Phase 4
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- history of AR in the previous year;
- positive skin prick test to seasonal allergens.
Who cannot join
- acute upper respiratory infections in the last 4 weeks;
- lifetime history of asthma (doctor diagnosis);
- use of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines in the last 4 weeks;
- anatomic nasal defects (ie, septum deviation), or nasal polyps;
- active smoker.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo
Palermo, 90146
About this study
Official title: ReNIM Study - Nebulized Resveratrol Plus Carboxymethyl-β-Glucan for Reducing Nasal Interleukin-5 (IL-5) Measurements in Children With Allergic Rhinitis
Single-center, randomized, placebo-controlled study to:
- characterize the subjects at baseline and discriminate groups of children based on IL-5, IL-17, IL-23 and INF-γ;
- investigate the effect of Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) for nostril three times/day for 4 weeks, in comparison with placebo, in reducing nasal interleukin-5 (IL-5) in children with Allergic Rhinitis (AR).
Secondary objectives are to examine the effect of resveratrol plus carboxymethyl-β-glucan, in comparison with placebo, on subjective parameters, i.e. symptom scores, visual analogue scales for rhinitis, quality of life and quality of sleep, and the effect on objective parameters, i.e. nasal nitric oxide (nNO) levels, nasal cytology and acoustic rhinometry.
- Conditions
- Allergic Rhinitis
- Being tested
- Resveratrol plus Carboxymethyl-β-Glucan, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol plus Carboxymethyl-β-GlucanDrug
Patients in this arm will receive Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) per nostril three times/day for 4 weeks
PlaceboDrug
Patients in this arm will receive nasal saline solution 0.9%, two sprays per nostril, three times/day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol plus Carboxymethyl-β-Glucan | Experimental | Not described Receives: Drug: Resveratrol plus Carboxymethyl-β-Glucan |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Interleukin-17 (IL-17)
IL-17 level at baseline
Measured: Baseline
Nasal Interleukin-23 (IL-23)
IL-23 level at baseline
Measured: Baseline
Nasal Interferon-γ (INF-γ)
INF-γ level at baseline
Measured: Baseline
Nasal PH
Nasal PH at baseline
Measured: Baseline
Nasal Interleukin-5 (IL-5)
Mean change in IL-5 level from baseline to the end of treatment.
Measured: Baseline and 28 days
Secondary outcomes (8)
Total 5 Symptom Score (T5SS)
Mean change in T5SS score from baseline to the end of treatment.
Measured: Baseline and 28 days
Visual Analogue Scale for Rhinitis (VAS)
Mean change in VAS score from baseline to the end of treatment.
Measured: Baseline and 28 days
Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
Mean change in PRQLQ score from baseline to the end of treatment.
Measured: Baseline and 28 days
Pittsburgh Sleep Quality Index (PSQI)
Mean change in PSQI score from baseline to the end of treatment.
Measured: Baseline and 28 days
Nasal Exhaled Nitric Oxide (nNO)
Mean change of nNO from baseline to the end of treatment.
Measured: Baseline and 28 days
Nasal Cytology
Mean change in nasal cytology counts from baseline to the end of treatment.
Measured: Baseline and 28 days
Acoustic Rhinometry: Minimal Cross-sectional Area (MCA)
Mean change of MCA from baseline to the end of treatment.
Measured: Baseline and 28 days
Acoustic Rhinometry: Nasal Volume from the first 5 cm from the nostril (V.0-5)
Mean change of V.0-5 from baseline to the end of treatment.
Measured: Baseline and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start5 Mar 2018
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349619
- Sponsor's protocol ID
- 10/2017
- Acronym
- RENIM
- Status last verified
- Dec 2019
- First submitted
- 17 Nov 2017
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReNIM Study - Nebulized Resveratrol Plus Carboxymethyl-β-Glucan for Reducing Nasal Interleukin-5 (IL-5) Measurements in Children With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT03349619
- Acronym / sponsor ID
- RENIM / 10/2017
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 21 Nov 2017 (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.
Single-center, randomized, placebo-controlled study to:
- characterize the subjects at baseline and discriminate groups of children based on IL-5, IL-17, IL-23 and INF-γ;
- investigate the effect of Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) for nostril three times/day for 4 weeks, in comparison with placebo, in reducing nasal interleukin-5 (IL-5) in children with Allergic Rhinitis (AR).
Secondary objectives are to examine the effect of resveratrol plus carboxymethyl-β-glucan, in comparison with placebo, on subjective parameters, i.e. symptom scores, visual analogue scales for rhinitis, quality of life and quality of sleep, and the effect on objective parameters, i.e. nasal nitric oxide (nNO) levels, nasal cytology and acoustic rhinometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol plus Carboxymethyl-β-Glucan | Experimental | Drug: Resveratrol plus Carboxymethyl-β-Glucan |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- history of AR in the previous year;
- positive skin prick test to seasonal allergens.
Key exclusion criteria (5 listed)
- acute upper respiratory infections in the last 4 weeks;
- lifetime history of asthma (doctor diagnosis);
- use of nasal or oral corticosteroids, nasal or oral decongestants, antihistamines in the last 4 weeks;
- anatomic nasal defects (ie, septum deviation), or nasal polyps;
- active smoker.
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 |
|---|---|---|
| Resveratrol plus Carboxymethyl-β-GlucanPatients in this arm will receive Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) per nostril three times/day for 4 weeks | Drug | Resveratrol plus Carboxymethyl-β-Glucan |
| PlaceboPatients in this arm will receive nasal saline solution 0.9%, two sprays per nostril, three times/day for 4 weeks | Drug | Placebo |
Primary outcome
Nasal Interleukin-17 (IL-17)
Time frame: Baseline
IL-17 level at baseline
Nasal Interleukin-23 (IL-23)
Time frame: Baseline
IL-23 level at baseline
Nasal Interferon-γ (INF-γ)
Time frame: Baseline
INF-γ level at baseline
Nasal PH
Time frame: Baseline
Nasal PH at baseline
Nasal Interleukin-5 (IL-5)
Time frame: Baseline and 28 days
Mean change in IL-5 level from baseline to the end of treatment.
8 secondary outcomes
Total 5 Symptom Score (T5SS)
Time frame: Baseline and 28 days
Visual Analogue Scale for Rhinitis (VAS)
Time frame: Baseline and 28 days
Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
Time frame: Baseline and 28 days
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 28 days
Nasal Exhaled Nitric Oxide (nNO)
Time frame: Baseline and 28 days
Nasal Cytology
Time frame: Baseline and 28 days
Acoustic Rhinometry: Minimal Cross-sectional Area (MCA)
Time frame: Baseline and 28 days
Acoustic Rhinometry: Nasal Volume from the first 5 cm from the nostril (V.0-5)
Time frame: Baseline and 28 days
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 5 Dec 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Resveratrol plus Carboxymethyl-β-Glucan in people with Allergic Rhinitis, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
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 2 inclusion and 5 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 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Nasal Interleukin-17 (IL-17) (time frame: Baseline). 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 5 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.