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B2-Adrenergic Receptor Polymorphisms

Sponsor
Connecticut Children's Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00279786
Collaborator
(none)
126
Enrollment
1
Location
37
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Beta(2)-adrenergic receptor (BAR) agonists are the most important group of drugs used in the treatment of asthma. In children unresponsive to inhaled BAR agonist therapy, higher dose systemic BAR agonist therapy is frequently the next step in treatment. Despite the widespread use of intravenous BAR agonist therapy for pediatric status asthmaticus, there is controversy regarding the efficacy of this therapy. A number of studies have established that genetic variations of the BAR have important effects in modulating responses to BAR agonist therapy for asthma. In particular, changes in amino acid position 16 of the BAR gene are thought to be the most functionally important. Patients encoded for two glycine amino acids, rather than arginine, at this position appear to have more severe asthma and to respond differently to acute BAR agonist therapy.

Our hypothesis is that genotypic differences may contribute to poor response to acute BAR agonist treatment. We propose to conduct a prospective observational study to determine the influence of a patient's BAR genotype on the response to acute BAR agonist therapy.

Our specific hypothesis is that children with genetic polymorphisms of the gene encoding the BAR will have a decreased response to acute high-dose continuous BAR therapy (both inhaled and intravenous) compared to other children.

Our primary outcome is ICU length of stay. Secondary outcomes are

  1. to assess the rate of improvement in clinical asthma score based on genotype, and

  2. to attempt to correlate asthma phenotype with genotype by comparing demographic data and hospital course.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood draw

Detailed Description

This study has both a prospective and a retrospective arm. In the retrospective arm, patients with a history of admission to the ICU with a severe asthma exacerbation are contacted by phone and mail and DNA samples are obtained via saliva. In the prospective arm, patients admitted to the ICU are contacted prospectively and DNA is obtained either via saliva or blood.

Study Design

Study Type:
Observational
Actual Enrollment :
126 participants
Observational Model:
Cohort
Official Title:
B2-Adrenergic Receptor Polymorphisms: Implications For The Treatment Of Status Asthmaticus In Children
Study Start Date :
Dec 1, 2005
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Jan 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • (1) Admission to the CCMC PICU with a primary admission diagnosis of status asthmaticus. (2) Age between 2 years and 18 years.
    Exclusion Criteria:
    • Pre-existing chronic disease (other than asthma)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CT Children's Medical Center Hartford Connecticut United States 06106

    Sponsors and Collaborators

    • Connecticut Children's Medical Center

    Investigators

    • Principal Investigator: Christopher Carroll, MD, CT Children's Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00279786
    Other Study ID Numbers:
    • 06-001
    First Posted:
    Jan 20, 2006
    Last Update Posted:
    Jul 28, 2009
    Last Verified:
    Jul 1, 2009
    Keywords provided by , ,
    pediatric
    Additional relevant MeSH terms:
    Status Asthmaticus

    Study Results

    No Results Posted as of Jul 28, 2009