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NCT02433275 Clinical Trial

CHildhood ASthma and Environment Research Study - CHASER Study

Asthma Clinical Trial

Official title:
CHildhood ASthma and Environment Research Study - CHASER Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02433275
Other study ID # 8/2014
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2011
Est. completion date December 2022

Study information
Verified date August 2022
Source Istituto per la Ricerca e l'Innovazione Biomedica
Contact Stefania La Grutta, MD
Phone +39-091-6809680
Email stefania.lagrutta@irib.cnr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

"CHildhood ASthma and Environment Research study - CHASER study" is an observational longitudinal study in outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy. The first phase - transversal study will identify determinants of pediatric asthma control The second phase - longitudinal study, in patients with persistent asthma, will be focused on: - predictors for asthma exacerbations and loss of control - real life adherence to asthma therapy guidelines - phenotypic characterization through the collection of saliva samples - assessment of alterations and inflammatory changes in the nasal mucosa through nasal brushing - evaluation of the presence of 8-isoprostane, nicotine, cotinine and bisphenol-A through urine analysis. Chaser Project is expected to improve the knowledge of pediatric asthma in patients with different level of control, identifying predictors for asthma exacerbations and loss of control.

Recruitment information / eligibility
Status Recruiting
Enrollment 1600
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 5 Years to 16 Years
Eligibility Inclusion Criteria: - age 5-16 years - asthma - not asthma Exclusion Criteria: - chest deformity - active smoking

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Institute of Biomedicine and Molecular Immunology, IBIM Palermo

Sponsors (1)
Lead Sponsor Collaborator
Stefania La Grutta, MD

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Asthma 5 years
Secondary Measures from saliva samples 5 years
Secondary Measures from nasal brushing 5 years
Secondary Measures from urine samples 5 years
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