RhinitisRhino-RepNCT03286049
Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age
An observational study of Rhinitis and Rhinitis, Allergic, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
Longitudinal, observational study to assess the short-term (test re-test) and mid-term (within the span of 28 days) repeatability of active anterior rhinomanometry (AAR) measures on 4 parallel groups of children with different rhinitis phenotypes, and 1 group of control (healthy) children. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinitis, Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2018to 31 Jul 2018
- 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A study population of 40 rhinitis children (10 for each of 4 different rhinitis phenotypes) attending the outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR), and a control group of 10 healthy volunteers.
Healthy volunteers (HC)
The inclusion criteria for HC are:
- Negative bronchodilator response;
- No major nasal septum malformations.
The exclusion criteria for HC are:
- Upper airway infections in the previous 4 weeks;
- Active smoker;
- Lifetime history of asthma, rhinitis, or respiratory disease symptoms.
Children with non allergic rhinitis (NAR)
The inclusion criteria for NAR are:
1.T5SS>5 in the last 4 weeks.
The exclusion criteria for NAR are:
- At least one positive skin prick test for aeroallergens;
- Upper airway infections in the previous 4 weeks;
- Active smoker;
- Major nasal septum malformations.
Rhinitis children, perennial allergy (PAR)
The inclusion criteria for PAR are:
- T5SS>5 in the last 4 weeks.
- At least one positive skin prick test for perennial aeroallergens;
The exclusion criteria for PAR are:
- At least one positive skin prick test for seasonal aeroallergens;
- Upper airway infections in the previous 4 weeks;
- Active smoker;
- Major nasal septum malformations.
Rhinitis children, seasonal allergy, outside season (OSR)
The inclusion criteria for OSR are:
- T5SS>5 in the last 4 weeks.
- At least one positive skin prick test for seasonal aeroallergens;
The exclusion criteria for OSR are:
- At least one positive skin prick test for perennial aeroallergens;
- Upper airway infections in the previous 4 weeks;
- Active smoker;
- Major nasal septum malformations.
Rhinitis children, seasonal allergy, within season (OSR)
The inclusion criteria for OSR are:
- T5SS>5 in the last 4 weeks.
- At least one positive skin prick test for seasonal aeroallergens;
The exclusion criteria for OSR are:
- At least one positive skin prick test for perennial aeroallergens;
- Upper airway infections in the previous 4 weeks;
- Active smoker;
- Major nasal septum malformations.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, 90146
About this study
Official title: Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age - Rhino-Rep
Longitudinal, observational study to assess the short-term (test re-test) and mid-term (within the span of 28 days) repeatability of active anterior rhinomanometry (AAR) measures on 4 parallel groups of children with different rhinitis phenotypes, and 1 group of control (healthy) children.
Secondary objectives are: i) assessing of association between AAR, exhaled FeNO (eFeNO) and nasal FeNO (nFeNO); ii) assessing association between objective measurements (AAR, eFeNO and nFeNO) and subjective measurements (Total 5 Symptom score, T5SS).
The study is intended to obtain useful information for improving rhinitis management.
- Medical subject headings
- Rhinitis, Rhinitis, Allergic, Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy children (HC) | 10 healthy children | |
| Children with non allergic rhinitis (NAR) | 10 children with non allergic rhinitis | |
| Rhinitis children, perennial allergy (PAR) | 10 rhinitis children, sensitized to perennial allergens | |
| Rhinitis children, seasonal allergy, outside season (OSR) | 10 rhinitis children sensitized to seasonal allergens, observed outside the allergen season | |
| Rhinitis children, seasonal allergy, within season (WSR) | 10 rhinitis children sensitized to seasonal allergens, observed during the allergen season |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term repeatability of active anterior rhinomanometry (AAR)
For each individual, it will be calculated the coefficient of variation of 5 measurements of AAR taken within 30 minutes, at baseline.
Measured: 1 day
Mid term repeatability of active anterior rhinomanometry (AAR)
For each individual, it will be calculated the coefficient of variation of 3 measurements of AAR taken at baseline and then twice more within the span of 28 days (after one week and after two weeks).
Measured: 28 days
Secondary outcomes (4)
Correlation between AAR and oral FeNO
Correlation coefficients between measurements of AAR and oral FeNO (at each visit the mean of 3 consecutive measurements of oral FeNO is considered)
Measured: 28 days
Correlation between AAR and nasal FeNO
Correlation coefficients between measurements of AAR and nasal FeNO (at each visit the mean of 3 consecutive measurements of nasal FeNO is considered)
Measured: 28 days
Correlation between AAR (objective perspective) and T5SS (subjective perspective)
Correlation coefficients between measurements of AAR and total 5 symptom score
Measured: 28 days
Correlation between FeNO (objective perspective) and T5SS (subjective perspective)
Correlation coefficients between measurements of FeNO and total 5 symptom score
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start10 Jan 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT03286049
- Sponsor's protocol ID
- 7/2017_C
- Acronym
- Rhino-Rep
- Status last verified
- Nov 2018
- First submitted
- 5 Sep 2017
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cilluffo G, Zicari AM, Ferrante G, Malizia V, Fasola S, Duse M, De Castro G, De Vittori V, Schiavi L, Brindisi G, Petrelli P, La Grutta S. Assessing repeatability and reproducibility of Anterior Active Rhinomanometry (AAR) in children. BMC Med Res Methodol. 2020 Apr 17;20(1):86. doi: 10.1186/s12874-020-00969-1.
PubMed 32303189
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Mid-term Repeatability of Active Anterior Rhinomanometry (AAR) Measurements in Paediatric Age - Rhino-Rep
- ClinicalTrials.gov ID
- NCT03286049
- Acronym / sponsor ID
- Rhino-Rep / 7/2017_C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 18 Sep 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.
Longitudinal, observational study to assess the short-term (test re-test) and mid-term (within the span of 28 days) repeatability of active anterior rhinomanometry (AAR) measures on 4 parallel groups of children with different rhinitis phenotypes, and 1 group of control (healthy) children.
Secondary objectives are: i) assessing of association between AAR, exhaled FeNO (eFeNO) and nasal FeNO (nFeNO); ii) assessing association between objective measurements (AAR, eFeNO and nFeNO) and subjective measurements (Total 5 Symptom score, T5SS).
The study is intended to obtain useful information for improving rhinitis management.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy children (HC) | – | –10 healthy children |
| Children with non allergic rhinitis (NAR) | – | –10 children with non allergic rhinitis |
| Rhinitis children, perennial allergy (PAR) | – | –10 rhinitis children, sensitized to perennial allergens |
| Rhinitis children, seasonal allergy, outside season (OSR) | – | –10 rhinitis children sensitized to seasonal allergens, observed outside the allergen season |
| Rhinitis children, seasonal allergy, within season (WSR) | – | –10 rhinitis children sensitized to seasonal allergens, observed during the allergen season |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A study population of 40 rhinitis children (10 for each of 4 different rhinitis phenotypes) attending the outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR), and a control group of 10 healthy volunteers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short term repeatability of active anterior rhinomanometry (AAR)
Time frame: 1 day
For each individual, it will be calculated the coefficient of variation of 5 measurements of AAR taken within 30 minutes, at baseline.
Mid term repeatability of active anterior rhinomanometry (AAR)
Time frame: 28 days
For each individual, it will be calculated the coefficient of variation of 3 measurements of AAR taken at baseline and then twice more within the span of 28 days (after one week and after two weeks).
4 secondary outcomes
Correlation between AAR and oral FeNO
Time frame: 28 days
Correlation between AAR and nasal FeNO
Time frame: 28 days
Correlation between AAR (objective perspective) and T5SS (subjective perspective)
Time frame: 28 days
Correlation between FeNO (objective perspective) and T5SS (subjective perspective)
Time frame: 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 16 Nov 2018.
- Derived from this study: PubMed 32303189Cilluffo G, Zicari AM, Ferrante G, Malizia V, Fasola S, Duse M, De Castro G, De Vittori V, Schiavi L, Brindisi G, Petrelli P, La Grutta S. Assessing repeatability and reproducibility of Anterior Active Rhinomanometry (AAR) in children. BMC Med Res Methodol. 2020 Apr 17;20(1):86. doi: 10.1186/s12874-020-00969-1.
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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?
An observational study of Rhinitis and Rhinitis, Allergic, 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?
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 16 Nov 2018. 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. 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?
Short term repeatability of active anterior rhinomanometry (AAR) (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT03286049, 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 16 Nov 2018.