Asthma Clinical Trial
Official title:
Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)
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.
BACKGROUND:
The purpose of this study is to compare the effects of a long-acting beta agonist in patients
with asthma receiving inhaled corticosteroids who express two distinct polymorphisms of the
beta-2 adrenergic receptor.
DESIGN NARRATIVE:
Participants were homozygous for arginine or glycine at the 16th amino-acid position of the
β-2 adrenergic receptor (B16 Arg/Arg or B16 Gly/Gly). Individuals were matched against their
opposite genotype by forced expiratory volume in one second (FEV1) and race. Matched
participants entered an 8-week run-in period. This is a 62-week crossover design where
subjects receive the following therapies:
- Beclomethasone HFA (240 µg twice a day (BID)) + as-needed (PRN) albuterol: 8-week run-in
- Beclomethasone HFA (240 µg BID) + salmeterol (50 µg BID) + PRN ipratropium bromide + PRN
albuterol: 18-week treatment period
- Beclomethasone HFA (240 µg BID) + PRN albuterol: 8-week run-out
- Beclomethasone HFA (240 µg BID) + placebo salmeterol + PRN ipratropium bromide + PRN
albuterol: 18-week treatment period
- Beclomethasone HFA (240 µg BID) + PRN albuterol: 10-week run-out
The order of treatments received during the two treatment periods is randomized.
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