RAPP-children, Rhinitis & Asthma in Patient Perspective: Development and Validation of a Questionnaire for Quality of Life Evaluation in Children With Asthma and Allergic Rhinitis (RAPP)

September 25, 2019 updated by: Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica

This observational study aims at developing and validating a simple questionnaire to be routinely applied in the clinical practice, for the evaluation of the quality of life in children with concomitant asthma and allergic rhinitis. The study consists of two phases:

Phase 1: Development of the RAPP-children questionnaire starting from the validated RHINASTHMA-children questionnaire.

Phase 2: Administration and validation of the RAPP-children questionnaire. 150 children with concomitant asthma and allergic rhinitis will be followed-up for one month. Both at baseline and after one month, the RAPP children and several other standardized questionnaires will be administered.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sicily
      • Palermo, Sicily, Italy, 90146
        • Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A study population of 150 children with concomitant asthma and allergic rhinitis, aged 6 to 11 years, both males and females, followed-up for one month at the outpatient clinic of Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).

Description

Inclusion Criteria:

  • Age between 6 and 11 years
  • Concomitant asthma and allergic rhinitis
  • Males and Females

Exclusion Criteria:

  • Immunological and metabolic systemic disease
  • Major malformations of the upper airways
  • Active smoker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
150 children with concomitant asthma and rhinitis
Baseline and one-month administration of RAPP-children, RHINASTHMA-children, C-ACT, VAS, Kiddy KINDLE, GRS. Baseline and one-month spirometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RAPP-children response patterns
Time Frame: 1 months
Multivariate analyses of the responses to the RAPP-children questions
1 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RHINASTHMA-children response patterns
Time Frame: 1 months
Frequency distributions of the responses to the RHINASTHMA-children
1 months
C-ACT response patterns
Time Frame: 1 months
Frequency distributions of the responses to the C-ACT (Childhood Asthma Control Test)
1 months
VAS response pattern
Time Frame: 1 months
Frequency distribution of the response to the VAS (Visual Analog Scale)
1 months
Kiddy-KINDL response patterns
Time Frame: 1 months
Frequency distributions of the response to the Kiddy-KINDL
1 months
Pulmonary function: FEV1
Time Frame: 1 months
Forced expiratory volume in the first second
1 months
Pulmonary function: FVC
Time Frame: 1 months
Forced vital capacity
1 months
Pulmonary function: FEF25-75
Time Frame: 1 months
Forced expiratory flow at 25-75%
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 6, 2017

First Posted (Actual)

September 8, 2017

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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