"Studio NaVA" - National Study on Quality of Life in Adolescents Affected by Allergic Rhinitis With or Without Asthma

Completed

• Conditions: Asthma; Allergic Rhinitis
• Interventions: Other: Data Collection

• Registration Number: NCT02380495
• Lead Sponsor: Stefania La Grutta, MD

Brief 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 (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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-27
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-05
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-18
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• 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.

Exclusion Criteria

• Subjects that have not allergic rhinitis with/without asthma diagnosis or are <14 years old or >17 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Allergic rhinitis with/without asthma, from 14 to 17 years age	Data Collection	600 adolescents with allergic rhinitis with/without asthma, from 14 to 17 years age, recruited from Pediatricians of the Italian territory.
Without respiratory pathology	Data Collection	600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology (patient family)

Primary Outcome Measures

Name	Time	Method
Assessment of the allergic rhinitis impact on quality of life	2 weeks

Secondary Outcome Measures

Name	Time	Method
The impact of AR and asthma on quality of sleep	2 weeks

Trial Locations

Locations (2)

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council; 🇮🇹 Palermo, Sicily, Italy

Institute of Biomedicine and Molecular Immunology, IBIM; 🇮🇹 Palermo, Italy