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

Completed

• Conditions: Allergic Rhinitis; Asthma
• Interventions: Other: CARATKids Questionnaire

• Registration Number: NCT02409550
• Lead Sponsor: Stefania La Grutta, MD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-24
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-07
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-14
• Last Update Posted: 2016-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
113 patients with concomitant asthma and allergic rhinitis	CARATKids Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
CARATKids Italian language validation	3 weeks	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.

Trial Locations

Locations (1)

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