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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00952835
Other study ID # AOV-1716
Secondary ID
Status Recruiting
Phase N/A
First received August 3, 2009
Last updated June 18, 2013
Start date July 2009
Est. completion date December 2014

Study information

Verified date June 2013
Source Universita di Verona
Contact Attilio Boner, MD
Phone --390458124615
Email attilio.boner@univr.it
Is FDA regulated No
Health authority Italy: National Bioethics Committee
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 5 Years and older
Eligibility Inclusion Criteria:

- patient with asthma and rhinitis

Exclusion Criteria:

- age <5 years

- chronic respiratory diseases

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
regular treatment
regular treatment

Locations

Country Name City State
Italy Pediatric department University of Verona Verona

Sponsors (2)

Lead Sponsor Collaborator
Universita di Verona Azienda Ospedaliera Universitaria Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis Yes
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