Asthma Clinical Research Network (ACRN) Beta Adrenergic Response by Genotype (BARGE)

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Accession Number
HLB00720909a

Study Type
Clinical Trial

Collection Type
Open BioLINCC Study See bottom of this webpage for request information

Study Period
1993-2008

NHLBI Division
DLD

Dataset(s) Last Updated
January 3, 2018

Consent

Commercial Use Data Restrictions No

Data Restrictions Based On Area Of Research No

Objectives

This project examined the use of regularly scheduled albuterol treatment in asthma, in a genotype-stratified, randomised, placebo-controlled cross-over trial in patients with mild asthma.

Background

The issue of whether regular use of an inhaled beta-adrenergic agonist worsens airflow and clinical outcomes in asthma is controversial. Retrospective studies have suggested that adverse effects occur in patients with a genetic polymorphism that results in homozygosity for arginine (Arg/Arg), rather than glycine (Gly/Gly), at aminoacid residue 16 of the beta-adrenergic receptor. However, the existence of any genotype-dependent difference has not been tested in a prospective clinical trial.

Subjects

A total of 338 Patients with mild asthma, 18-55 years of age, reporting use of inhaled beta agonist of less than 56 puffs per week as their only asthma treatment and with a forced expiratory volume in one second that was at least 70% of predicted were screened. Screened patients were then genotyped and those patients homozygous for Arg/Arg or Gly/Gly at the 16th aminoacid residue of the beta 2 adrenergic receptor were eligible for the study (180 patients). Of those eligible, 94 patients were matched and enrolled at the first visit (42 Arg/Arg and 52 Gly/Gly) and 78 were randomized (Arg/Arg n=37, four of 41 matches withdrew before randomisation; Gly/Gly n=41). Regularly scheduled treatment with albuterol or placebo was given in a masked, cross-over design, for 16-week periods.

Conclusions

Genotype at the 16th aminoacid residue of the beta-adrenergic receptor affects the long-term response to albuterol use. Bronchodilator treatments avoiding albuterol may be appropriate for patients with the Arg/Arg genotype (Lancet 2004; 364: 1505-12).

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Study Documents

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