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NCT02380495 Clinical Trial

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

Asthma Clinical Trial

Official title:
Studio NaVA - Studio Nazionale Sulla Qualità Della Vita in Adolescenti Con Rinite Allergica Con e Senza Asma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02380495
Other study ID # Verbale n°13/2013
Secondary ID
Status Completed
Phase N/A
First received February 27, 2015
Last updated May 18, 2017
Start date March 2015
Est. completion date March 2017

Study information
Verified date May 2017
Source Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 (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.

Recruitment information / eligibility
Status Completed
Enrollment 1200
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 14 Years to 17 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Data Collection

Locations
Country Name City State
Italy Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council Palermo Sicily
Italy Institute of Biomedicine and Molecular Immunology, IBIM Palermo

Sponsors (1)
Lead Sponsor Collaborator
Stefania La Grutta, MD

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of the allergic rhinitis impact on quality of life 2 weeks
Secondary The impact of AR and asthma on quality of sleep 2 weeks
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