Rhinitis, AllergicNCT06139185
The ARHINASD (Allergic Rhinitis in Pediatric Subjects With Nasal Septum Deviation) Project
An observational study of Rhinitis, Allergic, run by Federico II University at 2 sites in Italy.
Trial summary
Allergic rhinitis is one of the most common inflammatory conditions of the upper airway mucosa, especially in the pediatric population with a prevalence of approximately 25%. It is among the most common chronic inflammatory diseases globally and is caused by IgE-mediated reactions to inhaled allergens, often… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Rhinitis, Allergic
- What is being tested?
- Data collection
- How many people
- 69 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2023to 1 Jul 2024
- Phase
- Observational
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Caucasian children of both sexes aged between 6 and 14 with and without suspected deviation of the nasal septum observed at Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II), University of Calabria (Department of Pharmacy, Health and Nutrition Sciences) and Otorhinolaryngology Unit, Penne Hospital, ASL of Pescara
Who may be able to join
- Caucasian ethnicity
- both sexes
- age between 6 and 14 years
- written informed consent.
Who cannot join
- Non-Caucasian ethnicity
- Age <6 and >14 years
- Concomitant presence of:
- chronic diseases
- malignancies
- immunodeficiency
Show all 26Show fewer
- chronic infections
- autoimmune diseases
- chronic inflammatory intestinal diseases
- celiac disease
- genetic diseases
- metabolic diseases
- cystic fibrosis
- chronic pulmonary diseases
- malformations of the cardiovascular system
- malformations of the respiratory system
- malformations of the gastrointestinal system
- neuropsychiatric disorders
- neurological diseases
- obesity
- eosinophilic diseases
- antibiotics use in the last 7 days
- cortisone use in the last 7 days
- antihistamines use in the last 7 days
- trauma at nose level in the 3 years before the enrollment,
- history of previous nose surgery, or previous major surgery procedures of gastrointestinal, cardiovascular, urinary or respiratory tract
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Department of Traslational Medical Science - University of Naples Federico II
Naples, 80131
University of Naples Federico II
Naples
About this study
Official title: "ASSOCIATION BETWEEN NASAL SEPTUM DEVIATION AND ALLERGIC RHINITIS IN PEDIATRIC AGE: The ARHINASD (Allergic Rhinitis in Pediatric Subjects With Nasal Septum Deviation) Project"
Allergic rhinitis is one of the most common inflammatory conditions of the upper airway mucosa, especially in the pediatric population with a prevalence of approximately 25%. It is among the most common chronic inflammatory diseases globally and is caused by IgE-mediated reactions to inhaled allergens, often co-occurring with asthma and causing severe burdens and disabilities worldwide. Allergic rhinitis can in fact seriously compromise the quality of life, significantly influencing school performance, social life and the quality of sleep. It is known that the most common symptoms characterizing allergic rhinitis (itching of the nose, sneezing, rhinorrhea and nasal/sinus obstruction) are partly overlapping with those due to a condition of deviation of the nasal septum and a recent study has shown how 87 % of patients with persistent allergic rhinitis are affected by at least 1 of the 7 types of nasal septum deformity. Deviation of the nasal septum is a very frequent anatomical disorder and is present in up to 48% of children and adolescents in the general population. The deviation narrows the affected nostril canal, reducing the flow of air that passes through the nostrils, predisposing to chronic mucosal inflammation with inflammatory infiltrate and in turn increasing the risk of developing chronic rhinitis and sinusitis. There are no data in the literature that correlate nasal septum deviation with an increased risk of developing allergic rhinitis. Given these premises, the ARHINASD (Allergic Rhinitis in pediatric topics with Nasal Septum Deviation) study was designed with the primary objective of evaluating the presence of allergic rhinitis in a sample of patients with and without deviation of the nasal septum.
- Conditions
- Rhinitis, Allergic
- Being tested
- Data collection
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection
| Study group | Role | What they receive |
|---|---|---|
| Patients with nasal septum deviation | Not described Receives: Other: Data collection | |
| Patients without nasal septum deviation | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of allergic rhinitis
Complete clinical and anamnestic evaluation and allergy screening test (Skin-Prick Test).
Measured: 12 months
Secondary outcomes (5)
Total IgE of nasal wash supernatant
ELISA kit
Measured: 12 months
Cytokines (IL-13, IL-9, IL-33, IL-5, INFγ, β-defensin, IL-17, TNFα) of nasal wash supernatant
ELISA kit
Measured: 12 months
Quality of life questionnaire
Quality of life questionnaire (VAS)
Measured: 12 months
Peak inspiratory nasal flow
PNIF test
Measured: 12 months
Nasal cytology
Performed with the nasal scraping to obtain cells which are then stained with May-Grunwald and Giemsa staining and observed using an optical microscope
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139185
- Sponsor's protocol ID
- 31/23
- Status last verified
- Sep 2025
- First submitted
- 15 Nov 2023
- Last updated
- 23 Sep 2025
- Results posted
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "ASSOCIATION BETWEEN NASAL SEPTUM DEVIATION AND ALLERGIC RHINITIS IN PEDIATRIC AGE: The ARHINASD (Allergic Rhinitis in Pediatric Subjects With Nasal Septum Deviation) Project"
- ClinicalTrials.gov ID
- NCT06139185
- Acronym / sponsor ID
- 31/23
- Conditions
- Rhinitis, Allergic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 18 Nov 2023 (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.
Allergic rhinitis is one of the most common inflammatory conditions of the upper airway mucosa, especially in the pediatric population with a prevalence of approximately 25%. It is among the most common chronic inflammatory diseases globally and is caused by IgE-mediated reactions to inhaled allergens, often co-occurring with asthma and causing severe burdens and disabilities worldwide. Allergic rhinitis can in fact seriously compromise the quality of life, significantly influencing school performance, social life and the quality of sleep. It is known that the most common symptoms characterizing allergic rhinitis (itching of the nose, sneezing, rhinorrhea and nasal/sinus obstruction) are partly overlapping with those due to a condition of deviation of the nasal septum and a recent study has shown how 87 % of patients with persistent allergic rhinitis are affected by at least 1 of the 7 types of nasal septum deformity. Deviation of the nasal septum is a very frequent anatomical disorder and is present in up to 48% of children and adolescents in the general population. The deviation narrows the affected nostril canal, reducing the flow of air that passes through the nostrils, predisposing to chronic mucosal inflammation with inflammatory infiltrate and in turn increasing the risk of developing chronic rhinitis and sinusitis. There are no data in the literature that correlate nasal septum deviation with an increased risk of developing allergic rhinitis. Given these premises, the ARHINASD (Allergic Rhinitis in pediatric topics with Nasal Septum Deviation) study was designed with the primary objective of evaluating the presence of allergic rhinitis in a sample of patients with and without deviation of the nasal septum.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with nasal septum deviation | – | Other: Data collection |
| Patients without nasal septum deviation | – | Other: Data collection |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Caucasian children of both sexes aged between 6 and 14 with and without suspected deviation of the nasal septum observed at Pediatrics Section of Department of Translational Medical Sciences (University of Naples Federico II), University of Calabria (Department of Pharmacy, Health and Nutrition Sciences) and Otorhinolaryngology Unit, Penne Hospital, ASL of Pescara
Key inclusion criteria (4 listed)
- Caucasian ethnicity
- both sexes
- age between 6 and 14 years
- written informed consent.
Key exclusion criteria (26 listed)
- Non-Caucasian ethnicity
- Age <6 and >14 years
- chronic diseases
- malignancies
- immunodeficiency
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 |
|---|---|---|
| Data collectionData collection | Other | Patients with nasal septum deviation, Patients without nasal septum deviation |
Primary outcome
Presence of allergic rhinitis
Time frame: 12 months
Complete clinical and anamnestic evaluation and allergy screening test (Skin-Prick Test).
5 secondary outcomes
Total IgE of nasal wash supernatant
Time frame: 12 months
Cytokines (IL-13, IL-9, IL-33, IL-5, INFγ, β-defensin, IL-17, TNFα) of nasal wash supernatant
Time frame: 12 months
Quality of life questionnaire
Time frame: 12 months
Peak inspiratory nasal flow
Time frame: 12 months
Nasal cytology
Time frame: 12 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 23 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, Allergic, run by Federico II University at 2 sites 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 4 inclusion and 26 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 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Presence of allergic rhinitis (time frame: 12 months). 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 23 Sep 2025.