- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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 (RAPP)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Sicily
-
Palermo, Sicily, Italy, 90146
- Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RAPP-children response patterns
Time Frame: 1 months
|
Multivariate analyses of the responses to the RAPP-children questions
|
1 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RHINASTHMA-children response patterns
Time Frame: 1 months
|
Frequency distributions of the responses to the RHINASTHMA-children
|
1 months
|
C-ACT response patterns
Time Frame: 1 months
|
Frequency distributions of the responses to the C-ACT (Childhood Asthma Control Test)
|
1 months
|
VAS response pattern
Time Frame: 1 months
|
Frequency distribution of the response to the VAS (Visual Analog Scale)
|
1 months
|
Kiddy-KINDL response patterns
Time Frame: 1 months
|
Frequency distributions of the response to the Kiddy-KINDL
|
1 months
|
Pulmonary function: FEV1
Time Frame: 1 months
|
Forced expiratory volume in the first second
|
1 months
|
Pulmonary function: FVC
Time Frame: 1 months
|
Forced vital capacity
|
1 months
|
Pulmonary function: FEF25-75
Time Frame: 1 months
|
Forced expiratory flow at 25-75%
|
1 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Otorhinolaryngologic Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Asthma
- Rhinitis
- Rhinitis, Allergic
Other Study ID Numbers
- 7/2017_A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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