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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 (RAPP)

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ClinicalTrials.gov Identifier: NCT03276416
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Stefania La Grutta, MD, Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy

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. 130 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.


Condition or disease
Asthma Allergic Rhinitis

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
130 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.



Primary Outcome Measures :
  1. RAPP-children non-response rates [ Time Frame: 1 months ]
    The percentage of children which do not answer the RAPP-children questions


Secondary Outcome Measures :
  1. RAPP-children response patterns [ Time Frame: 1 months ]
    Frequency distributions of the responses to the RAPP-children questions

  2. RHINASTHMA-children response patterns [ Time Frame: 1 months ]
    Frequency distributions of the responses to the RHINASTHMA-children

  3. C-ACT response patterns [ Time Frame: 1 months ]
    Frequency distributions of the responses to the C-ACT (Childhood Asthma Control Test)

  4. VAS response pattern [ Time Frame: 1 months ]
    Frequency distribution of the response to the VAS (Visual Analog Scale)

  5. Kiddy-KINDL response patterns [ Time Frame: 1 months ]
    Frequency distributions of the response to the Kiddy-KINDL

  6. Pulmonary function: FEV1 [ Time Frame: 1 months ]
    Forced expiratory volume in the first second

  7. Pulmonary function: FVC [ Time Frame: 1 months ]
    Forced vital capacity

  8. Pulmonary function: FEF25-75 [ Time Frame: 1 months ]
    Forced expiratory flow at 25-75%



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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A study population of 130 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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276416


Contacts
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Contact: Stefania La Grutta, Ph.D. 0916809680 stefania.lagrutta@ibim.cnr.it
Contact: Giovanni Viegi, MD 0916809501 giovanni.viegi@ibim.cnr.it

Locations
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Italy
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council Recruiting
Palermo, Sicily, Italy, 90146
Contact: Stefania La Grutta, MD    +390916809680    stefania.lagrutta@ibim.cnr.it   
Sponsors and Collaborators
Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy

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Responsible Party: Stefania La Grutta, MD, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy., Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
ClinicalTrials.gov Identifier: NCT03276416     History of Changes
Other Study ID Numbers: 7/2017_A
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Rhinitis
Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases