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

Completed

• Conditions: Allergic Rhinitis; Asthma

• Registration Number: NCT03276416
• Lead Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-06
• Study First Posted: 2017-09-08
• Study Start: 2018-01-10
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RAPP-children response patterns	1 months	Multivariate analyses of the responses to the RAPP-children questions

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council; 🇮🇹 Palermo, Sicily, Italy