Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Single Dose, Placebo-controlled, Randomized, Double-blind, Double-dummy, Crossover Efficacy, Pharmacokinetics and Safety Comparison of Salmeterol Inhalation Powder (12.5 μg, 25 μg and 50 Salmeterol), Administered as the Xinafoate Salt From Hard Polyethylene Capsules Via the HandiHaler® 2, and Serevent® Diskus® (50 μg Salmeterol) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The primary objective of this trial was to establish non-inferiority of lung function
response to two doses [25 μg (1 capsule) and 50 μg (2 capsules of 25 μg)] salmeterol,
administered as the xinafoate salt, in an inhalation powder delivered from hard polyethylene
(PE) capsules via the HandiHaler® 2 compared to Serevent® Diskus® (salmeterol 50 μg,
administered as the xinafoate salt) following single dose inhalation in patients with COPD.
A hard capsule with half the strength (12.5 μg) was included to investigate a dose ordering
effect.
The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation
powder delivered by HandiHaler® 2 from the PE hard capsule(s) and salmeterol xinafoate
delivered by Serevent® Diskus®, and to compare the safety of the different pharmaceutical
forms and/or doses.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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