AsthmaNCT00952835
Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis
An observational study of Asthma and Rhinitis, run by Universita di Verona at 1 site in Italy.
Trial summary
In this study will be consecutive enrolled children with asthma (classified according to GINA guidelines) and rhinitis (classified by ARIA guidelines); the investigators will research clinical personal and parental history regarding allergic diseases, exposition to passive smoking and interpretate hematochemical… Read more about this study
- Who is it for?
- Ages 5 years and older
- What is being tested?
- regular treatment
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2009to Dec 2014
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: children with asthma and/or rhinitis visited at the outpatients clinic at the University of Verona will be invited to participate to the study
Who may be able to join
- patient with asthma and rhinitis
Who cannot join
- age <5 years
- chronic respiratory diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Pediatric department University of Verona
Verona, Verona, 37134
Attilio Boner, MD, --390458124615, attilio.boner@univr.it
Attilio Boner, MD
About this study
In this study will be consecutive enrolled children with asthma (classified according to GINA guidelines) and rhinitis (classified by ARIA guidelines); the investigators will research clinical personal and parental history regarding allergic diseases, exposition to passive smoking and interpretate hematochemical parameters markers of atopy. Skin Prick Tests will be performed. In this study the investigators will evaluate lung function parameters (spirometry with bronchial reversibility test and exercise induced bronchoconstriction, oscillometry, respiratory plethysmography, etc.), airway inflammatory indices such as exhaled nitric oxide at different flows, exhaled and nasal temperature, nasal cytology.
The aim of the study will be to evaluate possible correlation between these different parameters and clinical status of the patients.
Read the detailed description
Each patients will be evaluated by spirometry and then he will undergo exercise challenge in order to evaluate exercise-induced bronchoconstriction as a marker of asthma control. The test of the challenge will be correlate with childhood Asthma control test score,levels of control (GINA classification)and the different markers of airway inflammation and atopy.
- Being tested
- regular treatment
- Keywords
- Asthma, rhinitis, EIB, Exhaled Nitric oxide, lung function, vitamin d
- Medical subject headings
- Asthma, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular treatmentOther
Also called asthma treatment
regular treatment
| Study group | Role | What they receive |
|---|---|---|
| asthma and rhinitis control | Not described Receives: Other: regular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis
Measured: Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Policlinico
- Responsible party
- Principal investigator, Boner Attilio, Universita di Verona
- Investigators
- Attilio Boner, MD, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952835
- Sponsor's protocol ID
- AOV-1716
- Status last verified
- Jun 2013
- First submitted
- 3 Aug 2009
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Chinellato I, Piazza M, Peroni D, Sandri M, Chiorazzo F, Boner AL, Piacentini G. Bronchial and alveolar nitric oxide in exercise-induced bronchoconstriction in asthmatic children. Clin Exp Allergy. 2012 Aug;42(8):1190-6. doi: 10.1111/j.1365-2222.2012.03973.x.
PubMed 22805466Peroni DG, Cattazzo E, Chinellato I, Piazza M, Tezza G, Boner AL, Piacentini GL. Nasal mucosa temperature as a marker of disease in children with allergic rhinitis. Am J Rhinol Allergy. 2012 Jul-Aug;26(4):e115-8. doi: 10.2500/ajra.2012.26.3803.
PubMed 22801008
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis
- ClinicalTrials.gov ID
- NCT00952835
- Acronym / sponsor ID
- AOV-1716
- Keywords
- Asthma, rhinitis, EIB, Exhaled Nitric oxide, lung function, vitamin d
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Policlinico
- Study start
- Jul 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 6 Aug 2009 (estimated)
- 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.
In this study will be consecutive enrolled children with asthma (classified according to GINA guidelines) and rhinitis (classified by ARIA guidelines); the investigators will research clinical personal and parental history regarding allergic diseases, exposition to passive smoking and interpretate hematochemical parameters markers of atopy. Skin Prick Tests will be performed. In this study the investigators will evaluate lung function parameters (spirometry with bronchial reversibility test and exercise induced bronchoconstriction, oscillometry, respiratory plethysmography, etc.), airway inflammatory indices such as exhaled nitric oxide at different flows, exhaled and nasal temperature, nasal cytology.
The aim of the study will be to evaluate possible correlation between these different parameters and clinical status of the patients.
Detailed description
Each patients will be evaluated by spirometry and then he will undergo exercise challenge in order to evaluate exercise-induced bronchoconstriction as a marker of asthma control. The test of the challenge will be correlate with childhood Asthma control test score,levels of control (GINA classification)and the different markers of airway inflammation and atopy.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| asthma and rhinitis control | – | Other: regular treatment |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children with asthma and/or rhinitis visited at the outpatients clinic at the University of Verona will be invited to participate to the study
Key inclusion criteria (1 listed)
- patient with asthma and rhinitis
Key exclusion criteria (2 listed)
- age <5 years
- chronic respiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regular treatmentAlso: asthma treatmentregular treatment | Other | asthma and rhinitis control |
Primary outcome
Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis
Time frame: Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
- Derived from this study: PubMed 22805466Chinellato I, Piazza M, Peroni D, Sandri M, Chiorazzo F, Boner AL, Piacentini G. Bronchial and alveolar nitric oxide in exercise-induced bronchoconstriction in asthmatic children. Clin Exp Allergy. 2012 Aug;42(8):1190-6. doi: 10.1111/j.1365-2222.2012.03973.x.
- Derived from this study: PubMed 22801008Peroni DG, Cattazzo E, Chinellato I, Piazza M, Tezza G, Boner AL, Piacentini GL. Nasal mucosa temperature as a marker of disease in children with allergic rhinitis. Am J Rhinol Allergy. 2012 Jul-Aug;26(4):e115-8. doi: 10.2500/ajra.2012.26.3803.
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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.
Attilio Boner, MD principal investigator
Universita di Verona
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 Rhinitis, run by Universita di Verona 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Jun 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Attilio Boner, MD (--390458124615, attilio.boner@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis (time frame: Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis). 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 NCT00952835, which also lists 2 linked publications.
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 19 Jun 2013.