drugset / Trial / NCT03573817

A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD

NCT03573817

Phase 3 Completed 122 enrolled Mylan Inc. Theravance Biopharma · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study was to characterize the safety and tolerability of once-daily revefenacin inhalation solution when dosed sequentially with twice-daily formoterol inhalation solution (PERFOROMIST®) compared to PERFOROMIST®, in a population of participants with moderate-to-very severe Chronic Obstructive Pulmonary Disease (COPD) over 21 days.

Timeline

Start
2018-05-31
Primary completion
2018-09-25
Completion
2018-09-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Revefenacin Small molecule Other
Background Formoterol Other / unclassified Other