Who is sponsoring NCT02275481?

NCT02275481 is sponsored by Sumitomo Pharma America, Inc..

What condition does NCT02275481 study?

NCT02275481 studies Chronic Obstructive Pulmonary Disease (COPD).

What drugs are being tested in NCT02275481?

Interventions: Arformoterol tartrate inhalation solution, Tiotropium.

What is the status of NCT02275481?

NCT02275481 is currently TERMINATED.

Last reviewed 2018-06-01 · How we verify

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

NCT02275481 Phase 4 TERMINATED Results posted

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.

Details

Lead sponsor	Sumitomo Pharma America, Inc.
Phase	Phase 4
Status	TERMINATED
Enrolment	66
Start date	2014-11
Completion	2016-09-14

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Arformoterol tartrate inhalation solution
Tiotropium

Primary outcomes

Number of Participants Experiencing All-cause Hospitalization or Emergency Department Visit Within 90-days of Initiating Treatment — Up to 90 days
Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only summary tables and listings, disposition, demographics, vital signs, AEs and listings of safety data were generated.

Countries

United States