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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

I

Istituto per la Ricerca e l'Innovazione Biomedica

Status

Completed

Conditions

Asthma
Allergic Rhinitis

Study type

Observational

Funder types

Other

Identifiers

NCT03276416
7/2017_A

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

6 to 11 years old

Volunteers

No 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

Trial design

150 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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