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

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

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs TD-4208 350 μg; p <0.001; Difference of LS Mean 173.8 (95% CI 112.4 to 235.3); t-test, 2 sided NCT03064113 ↗

registry analysis (superiority test); Placebo vs TD-4208 700 μg; p <0.001; Difference of LS Mean 169.3 (95% CI 107.8 to 230.8); t-test, 2 sided NCT03064113 ↗

Publications

Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipratropium	Small molecule	500 ug	Other
Subject	Revefenacin	Small molecule	350 ug	Other
Subject	Revefenacin	Small molecule	700 ug	Other