Allergic RhinitisNCT02380495
"Studio NaVA" - National Study on Quality of Life in Adolescents Affected by Allergic Rhinitis With or Without Asthma
An observational study of Allergic Rhinitis and Asthma, run by Stefania La Grutta, MD at 2 sites in Italy.
Trial summary
"Studio Nava" is a National Study aiming to assess allergic rhinitis and asthma outcomes on Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. "Studio Nava" also proposes the innovative use of a web platform ("http://nava.ibim.cnr.it/") that contains all standardized tools… Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Allergic Rhinitis, Asthma
- What is being tested?
- Data Collection
- How many people
- 1,200 participants
- Where
- 2 sitesItaly
- Study dates
- Mar 2015to Mar 2017
- 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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: * 600 adolescents with allergic rhinitis with/without asthma, from 14 to 17 years age, recruited from Pediatricians of the Italian territory * 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology (patient family)
Who may be able to join
- Clinical cases n°: 600 adolescents affected by allergic rhinitis with/without asthma, from 14 to 17 years age.
- Controls n°: 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology.
Who cannot join
- Subjects that have not allergic rhinitis with/without asthma diagnosis or are <14 years old or >17 years old
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, 90146
Institute of Biomedicine and Molecular Immunology, IBIM
Palermo, 90146
About this study
Official title: Studio NaVA - Studio Nazionale Sulla Qualità Della Vita in Adolescenti Con Rinite Allergica Con e Senza Asma
"Studio Nava" is a National Study aiming to assess allergic rhinitis and asthma outcomes on Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. "Studio Nava" also proposes the innovative use of a web platform ("http://nava.ibim.cnr.it/") that contains all standardized tools (medical-healthcare web form, ACT, Asthma control test; PSQI, Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for adolescents; Rhinasthma; VAS scale), that will be available for the doctors after the registration to the web platform. Downloaded questionnaires will be delivered to case-patient, asking him/her to fill them during the waiting time of the visit.
- Conditions
- Allergic Rhinitis, Asthma
- Being tested
- Data Collection
- Keywords
- Adolescents, Respiratory Pathology
- Medical subject headings
- Rhinitis, Allergic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
| Study group | Role | What they receive |
|---|---|---|
| Allergic rhinitis with/without asthma, from 14 to 17 years age | 600 adolescents with allergic rhinitis with/without asthma, from 14 to 17 years age, recruited from Pediatricians of the Italian territory. Receives: Other: Data Collection | |
| Without respiratory pathology | 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology (patient family) Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the allergic rhinitis impact on quality of life
Measured: 2 weeks
Secondary outcomes (1)
The impact of AR and asthma on quality of sleep
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017
- Study completionMar 2017
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefania La Grutta, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380495
- Sponsor's protocol ID
- Verbale n°13/2013
- Status last verified
- May 2017
- First submitted
- 27 Feb 2015
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio NaVA - Studio Nazionale Sulla Qualità Della Vita in Adolescenti Con Rinite Allergica Con e Senza Asma
- ClinicalTrials.gov ID
- NCT02380495
- Acronym / sponsor ID
- Verbale n°13/2013
- Conditions
- Allergic Rhinitis, Asthma
- Keywords
- Adolescents, Respiratory Pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Stefania La Grutta, MDUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 5 Mar 2015 (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.
"Studio Nava" is a National Study aiming to assess allergic rhinitis and asthma outcomes on Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. "Studio Nava" also proposes the innovative use of a web platform ("http://nava.ibim.cnr.it/") that contains all standardized tools (medical-healthcare web form, ACT, Asthma control test; PSQI, Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for adolescents; Rhinasthma; VAS scale), that will be available for the doctors after the registration to the web platform. Downloaded questionnaires will be delivered to case-patient, asking him/her to fill them during the waiting time of the visit.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergic rhinitis with/without asthma, from 14 to 17 years age | – | Other: Data Collection600 adolescents with allergic rhinitis with/without asthma, from 14 to 17 years age, recruited from Pediatricians of the Italian territory. |
| Without respiratory pathology | – | Other: Data Collection600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology (patient family) |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- * 600 adolescents with allergic rhinitis with/without asthma, from 14 to 17 years age, recruited from Pediatricians of the Italian territory * 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology (patient family)
Key inclusion criteria (2 listed)
- Clinical cases n°: 600 adolescents affected by allergic rhinitis with/without asthma, from 14 to 17 years age.
- Controls n°: 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology.
Key exclusion criteria (1 listed)
- Subjects that have not allergic rhinitis with/without asthma diagnosis or are <14 years old or >17 years old
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 Collection | Other | Allergic rhinitis with/without asthma, from 14 to 17 years age, Without respiratory pathology |
Primary outcome
Assessment of the allergic rhinitis impact on quality of life
Time frame: 2 weeks
1 secondary outcome
The impact of AR and asthma on quality of sleep
Time frame: 2 weeks
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 19 May 2017.
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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 Allergic Rhinitis and Asthma, run by Stefania La Grutta, MD 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 2 inclusion and 1 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 19 May 2017. 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?
Assessment of the allergic rhinitis impact on quality of life (time frame: 2 weeks). 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 19 May 2017.