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

NCT ID: NCT02409550

Last Updated: 2016-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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Allergic Rhinitis Asthma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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113 patients with concomitant asthma and allergic rhinitis

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.

CARATKids Questionnaire

Intervention Type OTHER

Interventions

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CARATKids Questionnaire

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stefania La Grutta, MD

OTHER

Sponsor Role lead

Responsible Party

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Stefania La Grutta, MD

Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Institute of Biomedicine and Molecular Immunology, IBIM

Palermo, Palermo, Italy

Site Status

Countries

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Italy

Other Identifiers

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11/2014

Identifier Type: -

Identifier Source: org_study_id

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