Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)

Completed · Phase 3

Conditions studied: Asthma

In brief

The purpose of this trial is to determine whether regularly scheduled use of an inhaled long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly genotype.

Key facts

Study ID

NCT00200967

Run by

Milton S. Hershey Medical Center

People needed

87

Starts

2004-12-01

Expected to finish

2008-02-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, ages 18 and older
• Clinical history consistent with asthma
• For subjects regularly using inhaled corticosteroids, FEV1 50% of predicted, methacholine PC20 FEV1 16 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol
• For subjects not regularly using inhaled corticosteroids, FEV1 40% of predicted, methacholine PC20 FEV1 8 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol
• Genotype eligibility (determined during screening)

You may not qualify if…

• Smoker (total smoking history must be less than 10 pack years)
• Significant unstable medical condition other than asthma
• History of life-threatening asthma requiring treatment with intubation and mechanical ventilation in the past 10 years
• Pregnant or lactating

Where it is running

• University of California, San Diego — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• National Jewish Medical & Research Center — Denver, Colorado, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University of Wisconsin Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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