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

Asthma Clinical Trial

— RAPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276416
• Other study ID #: 7/2017_A
• Status: Completed
• Start date: January 10, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: September 2019
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Rhinitis
• Rhinitis, Allergic

Locations

Country	Name	City	State
Italy	Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council	Palermo	Sicily

Sponsors (1)

Lead Sponsor	Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica

Country where clinical trial is conducted

Italy, 

Outcome

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