The Genetics of Severe Asthma in Children

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Near fatal asthma exacerbations are one of the most common causes of critical illness in children, accounting for approximately ten thousand intensive care unit (ICU) admissions per year in the United States. Even children with intermittent or mild baseline asthma can develop these severe exacerbations; however, there are few studies evaluating the risk factors associated with the development of near fatal asthma exacerbations in children. Inhaled β2-adrenergic receptor (ADRβ2) agonist therapy is the foundation of therapy for acute asthma and genetic variations of this receptor have been shown to affect response to ADRβ2 agonist therapy in this population. The investigators hypothesis is that a child's ADRβ2 genotype is associated with the development of a near fatal asthma exacerbation.

Condition or disease
Asthma

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Study Design

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Study Type :	Observational
Estimated Enrollment :	200 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	The Genetics of Severe Asthma in Children
Study Start Date :	October 2009
Estimated Primary Completion Date :	April 2018
Estimated Study Completion Date :	April 2018

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Inpatient population; Children with asthma who are admitted to the hospital with an exacerbation.
Outpatient population; Children with asthma who have not been admitted to the hospital with an exacerbation.
Healthy controls; Children without asthma or any other chronic condition.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The primary end point is the development of a near fatal asthma exacerbation. [ Time Frame: 3 years ]

Secondary Outcome Measures :

1. The secondary end point is hospital length of stay. [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA

saliva and blood

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	4 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Children with asthma

Criteria

Inclusion Criteria, inpatient asthmatics:

• Admission to study institution with a primary admission diagnosis of asthma exacerbation
• Age between 4 and 18 years

Exclusion Criteria, inpatient asthmatics:

- Pre-existing chronic disease (other than asthma), including: i. bronchopulmonary dysplasia ii. bronchomalacia iii. tracheomalacia iv. laryngomalacia v. vocal cord dysfunction vi. chronic restrictive lung disease vii. recurrent aspiration pneumonia viii. impaired mucous clearance ix. congenital heart disease x. pulmonary hypertension

Inclusion Criteria, outpatient asthmatics:

• Diagnosis of asthma
• Age between 4 and 18 years

Exclusion Criteria, outpatient asthmatics:

• Previous admission to the hospital for a near fatal asthma exacerbation
• Pre-existing chronic disease (other than asthma) including i. bronchopulmonary dysplasia ii. bronchomalacia iii. tracheomalacia iv. laryngomalacia v. vocal cord dysfunction vi. chronic restrictive lung disease vii. recurrent aspiration pneumonia viii. impaired mucous clearance ix. congenital heart disease x. pulmonary hypertension

Inclusion Criteria, healthy controls:

- Age between 4 and 18 years

Exclusion Criteria, healthy controls:

- Pre-existing chronic disease including: i. asthma ii. bronchopulmonary dysplasia iii. bronchomalacia iv. tracheomalacia v. laryngomalacia vi. vocal cord dysfunction vii. chronic restrictive lung disease viii. recurrent aspiration pneumonia ix. impaired mucous clearance x. congenital heart disease xi. pulmonary hypertension

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Christopher L Carroll, MD, MS	860-545-9805	ccarrol@ccmckids.org

Locations

United States, Connecticut
Connecticut Children's Medical Center	Recruiting
Hartford, Connecticut, United States, 06103
Contact: Christopher L Carroll, MD, MS 860-545-9805 ccarrol@ccmckids.org

Sponsors and Collaborators

Connecticut Children's Medical Center

UConn Health

Investigators

Principal Investigator:	Christopher L Carroll, MD, MS	Connecticut Children's Medical Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Christopher Carroll, MD, Associate Professor of Pediatrics, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:	NCT01238432 History of Changes
Other Study ID Numbers:	08-103
First Posted:	November 10, 2010
Last Update Posted:	February 2, 2017
Last Verified:	January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Christopher Carroll, MD, Connecticut Children's Medical Center:

Pediatric; Polymorphism, Genetic; Adrenergic beta-Agonists

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases	Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases