B2-Adrenergic Receptor Polymorphisms

This study has been completed.
Sponsor:
Information provided by:
Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT00279786
First received: January 18, 2006
Last updated: July 27, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Status Asthmaticus
Procedure: Blood draw
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: B2-Adrenergic Receptor Polymorphisms: Implications For The Treatment Of Status Asthmaticus In Children

Resource links provided by NLM:


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

Enrollment: 126
Study Start Date: December 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Blood draw
    blood drawn
    Other Name: genotyping of ß2-AR at position 16 and 27.
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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children admitted to the ICU with severe asthma exacerbations

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279786

Locations
United States, Connecticut
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
  More Information

No publications provided

Responsible Party: Christopher Carroll, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT00279786     History of Changes
Other Study ID Numbers: 06-001
Study First Received: January 18, 2006
Last Updated: July 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Connecticut Children's Medical Center:
pediatric

Additional relevant MeSH terms:
Status Asthmaticus
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014