NCT02275481

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, open-label, parallel group, multicenter, outpatient study in COPD subjects who are discharged from the hospital following a COPD exacerbation. Subjects who meet the eligibility criteria will be randomized to 1 of 2 treatments. Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor. Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®. Study medications will be dispensed to the subject at Visit 1. The objective of the study is to determine the comparative effectiveness of arformoterol and tiotropium on re-hospitalization and to assess safety in Chronic Obstructive Pulmonary Disease (COPD) subjects recovering from hospitalization for an acute exacerbation.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Arformoterol tartrate inhalation solution	Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
DRUG	Tiotropium	Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-09-14
• Completion: 2016-09-14
• First posted: 2014-10-27
• Last updated: 2018-06-27
• Results posted: 2017-10-02

Locations

28 sites across 1 country: United States