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B2-Adrenergic Receptor Polymorphisms

NCT ID: NCT00279786

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Status Asthmaticus

Keywords

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pediatric

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Blood draw

blood drawn

Intervention Type PROCEDURE

Other Intervention Names

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genotyping of ß2-AR at position 16 and 27.

Eligibility Criteria

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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)
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Connecticut Children's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher Carroll, MD

Role: PRINCIPAL_INVESTIGATOR

CT Children's Medical Center

Locations

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CT Children's Medical Center

Hartford, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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06-001

Identifier Type: -

Identifier Source: org_study_id