B2-Adrenergic Receptor Polymorphisms

NCT00279786 | Completed

• 1 other identifier: 06-001
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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. 1.to assess the rate of improvement in clinical asthma score based on genotype, and
2. 2.to attempt to correlate asthma phenotype with genotype by comparing demographic data and hospital course.

Conditions

Status Asthmaticus

Keywords

pediatric

Interventions

Blood draw PROCEDURE

blood drawn

Also known as: genotyping of ß2-AR at position 16 and 27.

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children admitted to the ICU with severe asthma exacerbations

You may qualify if:

• (1) Admission to the CCMC PICU with a primary admission diagnosis of status asthmaticus. (2) Age between 2 years and 18 years.

You may not qualify if:

• Pre-existing chronic disease (other than asthma)

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

CT Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Status Asthmaticus

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christopher Carroll, MD

  CT Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2006
• First Posted: January 20, 2006
• Study Start: December 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: November 30, 2023

Record last verified: 2009-07

Locations

US (1)