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The Genetics of Severe Asthma in Children

This study is currently recruiting participants.
Verified January 2017 by Christopher Carroll, MD, Connecticut Children's Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238432
First Posted: November 10, 2010
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
UConn Health
Information provided by (Responsible Party):
Christopher Carroll, MD, Connecticut Children's Medical Center
  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

Resource links provided by NLM:


Further study details as provided by Christopher Carroll, MD, 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 ]

Secondary Outcome Measures:
  • The secondary end point is hospital length of stay. [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
saliva and blood

Estimated Enrollment: 200
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
UConn Health
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
First Submitted: November 8, 2010
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