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NCT02409550 Clinical Trial

CARATKids: Italian Validation of Asthma and Allergic Rhinitis Control Test in Children

Asthma Clinical Trial

Official title:
CARATKids: Italian Validation of Asthma and Allergic Rhinitis Control Test in Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02409550
Other study ID # 11/2014
Secondary ID
Status Completed
Phase N/A
First received March 24, 2015
Last updated July 14, 2016
Start date April 2015
Est. completion date July 2016

Study information
Verified date July 2016
Source Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
Contact n/a
Is FDA regulated No
Health authority Italy: National Bioethics Committee
Study type Observational

Clinical Trial Summary

This project is an observational study for the Italian language validation of the CARATKids questionnaire investigating the asthma and coexisting allergic rhinitis control in children. 113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months will be enrolled for the validation process at outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.

The study will be completed in two medical examination, within 3-6 weeks of each other.

CARATKids questionnaire, VAS (Visual Analogic Scale) and C-ACT (Children Asthma Control Test) will be filled by each patient.

The main outcome is the Italian language validation of the CARATKids questionnaire investigating the coexisting asthma and allergic rhinitis control in children.

Recruitment information / eligibility
Status Completed
Enrollment 113
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria:

- 113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months

- 12 < years old > 6

Exclusion Criteria:

- Patients with asthma only or allergic rhinitis only, or younger or older than the targeted age group

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• CARATKids Questionnaire

Locations
Country Name City State
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 CARATKids Italian language validation The main objective of the study is the assessment process of the tool CARATKids, in a scholastic children Italian population affected by coexisting asthma and allergic rhinitis. 3 weeks No
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