The efficacy of beta-agonists in elderly patients has not been extensively studied. We conducted a pooled analysis conducted across two 12-week, randomized, double-blind, double-dummy multicenter clinical trials to assess the efficacy of Foradil® (FOR) in an elderly subgroup population.
Forty patients ≥65 years of age with mild to moderate asthma had been randomized to receive formoterol (Foradil® dry powder inhalation capsules) 12μg b.i.d. (FOR12) or 24μg b.i.d. (FOR24) via the AerolizerTM, albuterol MDI 180μg q.i.d. (ALB) or placebo. FEV1 measurements were performed pre-dose, and 5, 15, 30 and 60 minutes and hourly through 12 hours post AM dose on the first day and every 4 weeks up to 12 weeks of treatment.
Effect on FEV1 in the elderly subgroup receiving 12 or 24μg formoterol b.i.d. were similar to the general population, showing clinically significant bronchodilation (> 15% increase in FEV1) throughout the 12-hour interval, [area under the FEV1 curve (AUC; primary endpoint)].
These results show that elderly patients with asthma achieved significantly greater and sustained bronchodilitation (>12 hours) with FOR than with multiple doses of ALB.
The elderly population is a growing subgroup of patients that need to be further studied. This small sample of data investigates the efficacy and safety of formoterol in an elderly subgroup.
Umit Yegen, EmployeeAUC of FEV1 (L x hours)FOR12 v PlaceboFOR24 v PlaceboFOR12 v 24ALB v PlaceboAfter first dose4.50*4.71*-0.212.53After 12 weeks4.024.17-0.151.54*
Indicates statistical significance at the 0.05 level