drugset / Trial / NCT03064113

Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT03064113

Phase 2 Completed 32 enrolled Mylan Inc. Theravance Biopharma · collab
RandomizedCrossoverQuadruple-blindTreatment

Summary

Thirty-two subjects diagnosed with COPD were enrolled, received each study treatment and completed the follow-up assessments. During each of the four study periods, subjects were admitted to the clinic on Day -1 and housed overnight until after the last spirometry measurement. Serial pulmonary function tests were performed and PK (pharmacokinetics) samples collected up to 25 hours. Subjects were discharged from the clinic on Day 2 after evaluations.

Timeline

Start
2011-05
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipratropium Small molecule 500 ug Other
Subject Revefenacin Small molecule 350 ug Other
Subject Revefenacin Small molecule 700 ug Other