At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Clinical history consistent with asthma
- ✓For ICS users: FEV1 ≥50% predicted, methacholine PC20 ≤16 mg/ml (or ≥12% and ≥200 ml FEV1 drop), and ≥12% FEV1 improvement after albuterol
- ✓For non-ICS users: FEV1 ≥40% predicted, methacholine PC20 ≤8 mg/ml (or ≥12% and ≥200 ml FEV1 drop), and ≥12% FEV1 improvement after albuterol
- ✕Smoking history ≥10 pack-years
- ✕Significant unstable medical condition other than asthma
- ✕History of life-threatening asthma requiring intubation and mechanical ventilation within past 10 years
- ✕Pregnant or lactating
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)
In Brief
A Phase 3 clinical trial evaluating salmeterol and beclomethasone HFA for Asthma. Completed, enrolled 87 participants across 7 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
50 micrograms (mcg) twice per day (BID) (Serevent 50 mcg diskus, GlaxoSmithKline (GSK), North Carolina)
240 mcg beclomethasone HFA (QVAR, Teva Pharmaceutical Industries)