The Genetics of Severe Asthma in Children

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2016 by Connecticut Children's Medical Center

Sponsor:

Collaborator:

University of Connecticut Health Center

Information provided by (Responsible Party):

Christopher Carroll, MD, Connecticut Children's Medical Center

ClinicalTrials.gov Identifier:

NCT01238432

First received: November 8, 2010

Last updated: January 27, 2016

Last verified: January 2016

History of Changes

Purpose

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
Asthma


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	The Genetics of Severe Asthma in Children

Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:

The primary end point is the development of a near fatal asthma exacerbation. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary end point is hospital length of stay. [ Time Frame: 3 years ] [ Designated as safety issue: No ]


Estimated Enrollment:	558
Study Start Date:	October 2009
Estimated Study Completion Date:	April 2018
Estimated Primary Completion Date:	April 2018 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility


Ages Eligible for Study:	4 Years to 18 Years (Child, Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238432

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

University of Connecticut Health Center

Investigators


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

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
Study First Received:	November 8, 2010
Last Updated:	January 27, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016

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