drugset / Trial / NCT02275481

A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects

NCT02275481

Phase 4 Terminated 66 enrolled Sumitomo Pharma America, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD subjects who are discharged from the hospital due to a COPD exacerbation. Subjects who meet the eligibility criteria will be randomized to 1 of 2 treatments: arformoterol tartrate inhalation solution (BROVANA) 15 mcg twice daily (BID) or tiotropium bromide (SPIRIVA) 18 mcg once daily (QD), each given for 90 days.

Timeline

Start
2014-11
Primary completion
2016-09-14
Completion
2016-09-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Arformoterol Small molecule 15 ug Inhaled
Comparator Tiotropium Other / unclassified 18 ug Inhaled