drugset / Trial / NCT01391559

Efficacy of Inhaling Bronchodilator Medications in Chronic Obstructive Pulmonary Disease

NCT01391559

RandomizedCrossoverOpen-labelTreatment

Summary

Some patients with Chronic Obstructive Pulmonary Disease (COPD) report that they are uncertain whether they achieve clinical benefit using a dry-powder inhaler (DPI). One possible explanation is that the patient is unable to inhale the dry powder bronchodilator medication into the lower respiratory tract due to a low peak inspiratory flow rate (PIFR). A PIFR \< 60 l/min is considered to be suboptimal flow for a DPI, including the Diskus device. The hypothesis of the study is that the forced expiratory volume in 1 second (FEV1) measured at two hours after inhalation of the study medication will be higher with arformoterol solution (15 mcg) from a nebulizer compared with salmeterol dry powder (50 mcg) inhaled from the Diskus.

Timeline

Start
2011-07
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Arformoterol Small molecule 15 ug Inhaled
Comparator Salmeterol Other / unclassified 50 ug Inhaled