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A SINGLE DOSE OF FORADIL PROVIDES SIGNIFICANTLY GREATER BRONCHODILATION THAT MULTIPLE DOSES OF ALBUTEROL OVER 12 HOURS IN OLDER ASTHMATICS

Novartis Pharmaceuticals Corporation, East Hanover, NJ

PURPOSE: 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.

METHODS: 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.

RESULTS: 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)].

CONCLUSION: These results show that elderly patients with asthma achieved significantly greater and sustained bronchodilitation (>12 hours) with FOR than with multiple doses of ALB.

CLINICAL IMPLICATIONS: 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.

DISCLOSURE: Umit Yegen, Employee

AUC of FEV1 (L x hours) FOR12 v Placebo FOR24 v Placebo FOR12 v 24 ALB v Placebo After first dose 4.50* 4.71* -0.21 2.53 After 12 weeks 4.02 4.17 -0.15 1.54

^* Indicates statistical significance at the 0.05 level