AsthmaRAPPNCT03276416
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
An observational study of Asthma and Allergic Rhinitis, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma, Allergic Rhinitis
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2018to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- Age between 6 and 11 years
- Concomitant asthma and allergic rhinitis
- Males and Females
Who cannot join
- Immunological and metabolic systemic disease
- Major malformations of the upper airways
- Active smoker
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, 90146
About this study
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
- Medical subject headings
- Asthma, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
RAPP-children response patterns
Multivariate analyses of the responses to the RAPP-children questions
Measured: 1 months
Secondary outcomes (7)
RHINASTHMA-children response patterns
Frequency distributions of the responses to the RHINASTHMA-children
Measured: 1 months
C-ACT response patterns
Frequency distributions of the responses to the C-ACT (Childhood Asthma Control Test)
Measured: 1 months
VAS response pattern
Frequency distribution of the response to the VAS (Visual Analog Scale)
Measured: 1 months
Kiddy-KINDL response patterns
Frequency distributions of the response to the Kiddy-KINDL
Measured: 1 months
Pulmonary function: FEV1
Forced expiratory volume in the first second
Measured: 1 months
Pulmonary function: FVC
Forced vital capacity
Measured: 1 months
Pulmonary function: FEF25-75
Forced expiratory flow at 25-75%
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start10 Jan 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276416
- Sponsor's protocol ID
- 7/2017_A
- Acronym
- RAPP
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2017
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32163631
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03276416
- Acronym / sponsor ID
- RAPP / 7/2017_A
- Conditions
- Asthma, Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (3 listed)
- Age between 6 and 11 years
- Concomitant asthma and allergic rhinitis
- Males and Females
Key exclusion criteria (3 listed)
- Immunological and metabolic systemic disease
- Major malformations of the upper airways
- Active smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RAPP-children response patterns
Time frame: 1 months
Multivariate analyses of the responses to the RAPP-children questions
7 secondary outcomes
RHINASTHMA-children response patterns
Time frame: 1 months
C-ACT response patterns
Time frame: 1 months
VAS response pattern
Time frame: 1 months
Kiddy-KINDL response patterns
Time frame: 1 months
Pulmonary function: FEV1
Time frame: 1 months
Pulmonary function: FVC
Time frame: 1 months
Pulmonary function: FEF25-75
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Derived from this study: PubMed 32163631Fasola 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergic Rhinitis, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RAPP-children response patterns (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03276416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.