NCT02433275

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,660

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

8.4 years

First QC Date

April 29, 2015

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Asthma

    5 years

Secondary Outcomes (3)

  • Measures from saliva samples

    5 years

  • Measures from nasal brushing

    5 years

  • Measures from urine samples

    5 years

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children

You may qualify if:

  • age 5-16 years
  • asthma
  • not asthma

You may not qualify if:

  • chest deformity
  • active smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Biomedicine and Molecular Immunology, IBIM

Palermo, Palermo, 90146, Italy

Location

Related Publications (3)

  • Cilluffo G, Ferrante G, Fasola S, Malizia V, Montalbano L, Ranzi A, Badaloni C, Viegi G, La Grutta S. Association between Asthma Control and Exposure to Greenness and Other Outdoor and Indoor Environmental Factors: A Longitudinal Study on a Cohort of Asthmatic Children. Int J Environ Res Public Health. 2022 Jan 4;19(1):512. doi: 10.3390/ijerph19010512.

  • Erkkola RA, Virta LJ, Vahlberg T, Jartti T. Prednisolone for the first rhinovirus induced wheezing reduces use of respiratory medication. Pediatr Allergy Immunol. 2022 Jan;33(1):e13668. doi: 10.1111/pai.13668. Epub 2021 Sep 29. No abstract available.

  • Cilluffo G, Han YY, Ferrante G, Dello Russo M, Lauria F, Fasola S, Montalbano L, Malizia V, Forno E, La Grutta S. The Dietary Inflammatory Index and asthma burden in children: A latent class analysis. Pediatr Allergy Immunol. 2022 Jan;33(1):e13667. doi: 10.1111/pai.13667. Epub 2021 Sep 27.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 4, 2015

Study Start

September 1, 2011

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The IPD collected will be available on December 2020.

Locations