Seasonal Allergic RhinitisPhase 3NCT02130440
Evaluation of the Beneficial Effects of a Nasal Spray of Resveratrol in Children With Seasonal Allergic Rhinitis
A Phase 3 study testing Resveratrol nasal spray in people with Seasonal Allergic Rhinitis, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Resveratrol nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2012to Apr 2014
- Phase
- Phase 3
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of both sexes, ranging in age from 4 to 17 years
- History of seasonal allergic rhinitis, mild, moderate or severe, defined according to the ARIA guidelines in 2010, documented by recurrent episodes in the previous year and confirmed by a positive skin test results
- Written informed consent from at least one parent or a legal representative
Who cannot join
- Lack of informed consent in writing by at least one parent or a legal representative
- Concomitant disorders, such as infection of the upper (sinusitis, etc..) or lower respiratory tract, nasal surgery in the last year, abnormalities of the respiratory tract, immune diseases
- Use of antihistamines, nasal or systemic corticosteroids, leukotriene modifiers, cromolyn sodium, in the last six weeks
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe.
Read the detailed description
The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe. The primary objective is to assess whether the treatment with nasal spray based resveratrol is able to improve the allergic rhinitis symptoms during the two months of treatment. The secondary aim is to evaluate if the resveratrol nasal spray is able to reduce respiratory infections and wheezing episodes.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Resveratrol nasal spray
- Keywords
- nasal obstruction, sneezing, itching, rhinorrhea, respiratory infections, wheezing
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Nasal Obstruction, Sneezing, Pruritus, Rhinorrhea, Respiratory Tract Infections, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol nasal sprayDrug
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol nasal spray | Active comparator | 2 sprays per nostril 3 times a day for a period of two months Receives: Drug: Resveratrol nasal spray |
| Placebo | Placebo comparator | 2 sprays per nostril 3 times a day for a period of two months Receives: Drug: Resveratrol nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal symptom severity
Nasal symptoms (itching, sneezing, rhinorrhea, and obstruction) will be scored by a four-point scale (0=no symptom; 1=mild; 2= moderate; 3= severe) and record by parents on a daily diary card.
Measured: two years
Secondary outcomes (7)
Cough
The cough presence and severity will be assessed during the day and the night by four-point scale and recorded by parents on a daily diary card.
Measured: two years
Wheezing
Wheezing will be assessed using the same four-point scale and record by parents on a daily diary card.
Measured: two year
Albuterol use
The albuterol use on demand will be record by parents on a daily diary card.
Measured: two years
Fever
The days with fever will be record by parents on a daily diary card.
Measured: two years
School absences
School absences will be record by a diary card.
Measured: two years
Antihistamines use
Evaluation of Cetirizine syrup on-demand use will be record by parents on a diary card
Measured: two years
Emergency visits
Emergency room visits for respiratory problems will be record by parents on a diary card.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michele Miraglia del Giudice, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130440
- Sponsor's protocol ID
- RESV_01
- Status last verified
- May 2014
- First submitted
- 25 Apr 2014
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Miraglia Del Giudice M, Maiello N, Capristo C, Alterio E, Capasso M, Perrone L, Ciprandi G. Resveratrol plus carboxymethyl-beta-glucan reduces nasal symptoms in children with pollen-induced allergic rhinitis. Curr Med Res Opin. 2014 Oct;30(10):1931-5. doi: 10.1185/03007995.2014.938731. Epub 2014 Jul 7.
PubMed 24983742
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Beneficial Effects of a Nasal Spray of Resveratrol in Children With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02130440
- Acronym / sponsor ID
- RESV_01
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- nasal obstruction, sneezing, itching, rhinorrhea, respiratory infections, wheezing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 May 2014 (estimated)
- 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.
The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe.
Detailed description
The aim of this study is to evaluate whether treatment with a nasal spray based on resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or severe. The primary objective is to assess whether the treatment with nasal spray based resveratrol is able to improve the allergic rhinitis symptoms during the two months of treatment. The secondary aim is to evaluate if the resveratrol nasal spray is able to reduce respiratory infections and wheezing episodes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol nasal spray | Active comparator | Drug: Resveratrol nasal spray2 sprays per nostril 3 times a day for a period of two months |
| Placebo | Placebo comparator | Drug: Resveratrol nasal spray2 sprays per nostril 3 times a day for a period of two months |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children of both sexes, ranging in age from 4 to 17 years
- History of seasonal allergic rhinitis, mild, moderate or severe, defined according to the ARIA guidelines in 2010, documented by recurrent episodes in the previous year and confirmed by a positive skin test results
- Written informed consent from at least one parent or a legal representative
Key exclusion criteria (3 listed)
- Lack of informed consent in writing by at least one parent or a legal representative
- Concomitant disorders, such as infection of the upper (sinusitis, etc..) or lower respiratory tract, nasal surgery in the last year, abnormalities of the respiratory tract, immune diseases
- Use of antihistamines, nasal or systemic corticosteroids, leukotriene modifiers, cromolyn sodium, in the last six weeks
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 nasal spray | Drug | Placebo, Resveratrol nasal spray |
Primary outcome
Nasal symptom severity
Time frame: two years
Nasal symptoms (itching, sneezing, rhinorrhea, and obstruction) will be scored by a four-point scale (0=no symptom; 1=mild; 2= moderate; 3= severe) and record by parents on a daily diary card.
7 secondary outcomes
Cough
Time frame: two years
Wheezing
Time frame: two year
Albuterol use
Time frame: two years
Fever
Time frame: two years
School absences
Time frame: two years
Antihistamines use
Time frame: two years
Emergency visits
Time frame: two years
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 May 2014.
- Derived from this study: PubMed 24983742Miraglia Del Giudice M, Maiello N, Capristo C, Alterio E, Capasso M, Perrone L, Ciprandi G. Resveratrol plus carboxymethyl-beta-glucan reduces nasal symptoms in children with pollen-induced allergic rhinitis. Curr Med Res Opin. 2014 Oct;30(10):1931-5. doi: 10.1185/03007995.2014.938731. Epub 2014 Jul 7.
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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 3 study testing Resveratrol nasal spray in people with Seasonal Allergic Rhinitis, run by University of Campania Luigi Vanvitelli 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 3 inclusion and 3 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 May 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 symptom severity (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02130440, which also lists 1 linked publication.
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 May 2014.