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 (25 μg Salmeterol), Administered as the Xinafoate Salt From a Hard Polyethylene Capsule 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 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.
The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation
powder delivered by HandiHaler® 2 from the PE hard capsule and salmeterol xinafoate
delivered by Serevent® Diskus®, and to compare the safety of the two pharmaceutical forms.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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