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

NCT03276416 | Completed

• 1 other identifier: 7/2017_A
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• RAPP-children response patterns

  Multivariate analyses of the responses to the RAPP-children questions

  1 months

Secondary Outcomes (7)

• RHINASTHMA-children response patterns

  1 months

• C-ACT response patterns

  1 months

• VAS response pattern

  1 months

• Kiddy-KINDL response patterns

  1 months

• Pulmonary function: FEV1

  1 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead

Study Sites (1)

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Palermo, Sicily, 90146, Italy

Location

Related Publications (1)

• Fasola S, Montalbano L, Ferrante G, Cilluffo G, Malizia V, Baiardini I, Braido F, Viegi G, La Grutta S. RAPP-children: A new tool for assessing quality of life in patients with asthma and rhinitis. Clin Exp Allergy. 2020 Jun;50(6):662-671. doi: 10.1111/cea.13599. Epub 2020 Mar 25.

  PMID: 32163631 DERIVED

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 8, 2017
• Study Start: January 10, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

IT (1)