CARATKids: Italian Validation of Asthma and Allergic Rhin... | NCT02409550

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

NCT02409550

Sponsor

Stefania La Grutta, MD

Status

Completed

Last Update Posted

Jul 15, 2016Estimated

Enrollment

113Actual

Phase

Not provided

Conditions

Allergic Rhinitis
Asthma

Interventions

CARATKids Questionnaire

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Mar 24, 2015

First Submission Date that Met QC Criteria

Apr 1, 2015

First Posted Date

Apr 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2016

Last Update Posted Date

Jul 15, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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., Istituto per la Ricerca e l'Innovazione BiomedicaSponsor-Investigator

Lead Sponsor

Stefania La Grutta, MDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

113Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Other: CARATKids Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CARATKids Questionnaire	Other		113 patients with concomitant asthma and allergic rhinitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Biomedicine and Molecular Immunology, IBIM		Palermo	Palermo	90146	Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The IPD collected will be available on May 2016.

The following participant data will be shared:

Asthma severity level
Asthma control level
Pulmonary function tests
Demographic characteristics All IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065631	Rhinitis, Allergic
D001249	Asthma

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided