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Completed

NCT Number: NCT03276416

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

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.

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Key information

Conditions

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

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Palermo, Sicily, 90146, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. RAPP-children response patterns

    Time frame: 1 months

    Multivariate analyses of the responses to the RAPP-children questions

Secondary outcomes

  1. RHINASTHMA-children response patterns

    Time frame: 1 months

    Frequency distributions of the responses to the RHINASTHMA-children

  2. C-ACT response patterns

    Time frame: 1 months

    Frequency distributions of the responses to the C-ACT (Childhood Asthma Control Test)

  3. VAS response pattern

    Time frame: 1 months

    Frequency distribution of the response to the VAS (Visual Analog Scale)

  4. Kiddy-KINDL response patterns

    Time frame: 1 months

    Frequency distributions of the response to the Kiddy-KINDL

  5. Pulmonary function: FEV1

    Time frame: 1 months

    Forced expiratory volume in the first second

  6. Pulmonary function: FVC

    Time frame: 1 months

    Forced vital capacity

  7. Pulmonary function: FEF25-75

    Time frame: 1 months

    Forced expiratory flow at 25-75%

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Registry information

Acronym: RAPP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 8, 2017
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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