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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03276416

Acronym

RAPP

Enrollment

150

Registered

2017-09-08

Start date

2018-01-10

Completion date

2019-07-31

Last updated

2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Asthma

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 11 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
RHINASTHMA-children response patterns	1 months	Frequency distributions of the responses to the RHINASTHMA-children
Pulmonary function: FVC	1 months	Forced vital capacity
Pulmonary function: FEF25-75	1 months	Forced expiratory flow at 25-75%
Pulmonary function: FEV1	1 months	Forced expiratory volume in the first second

Countries

Italy

Outcome results