A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Summary

The purpose of this study is to measure the safety and tolerability of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to tiotropium.

Timeline

Start

2015-09

Primary completion

2017-06

Completion

2017-06

Publications

• Ohar JA, Mahler DA, Davis GN, Lombardi DA, Moran EJ, Crater GD. Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow. Can Respir J. 2024 Mar 22;2024:8034923. doi: 10.1155/2024/8034923. eCollection 2024.
• Barnes CN, Mahler DA, Ohar JA, Lombardi DA, Crater GD. Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers. Chest. 2020 Oct;158(4):1413-1419. doi: 10.1016/j.chest.2020.03.072. Epub 2020 Apr 25.
• Donohue JF, Kerwin E, Sethi S, Haumann B, Pendyala S, Dean L, Barnes CN, Moran EJ, Crater G. Maintained therapeutic effect of revefenacin over 52 weeks in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). Respir Res. 2019 Oct 30;20(1):241. doi: 10.1186/s12931-019-1187-7.
• Donohue JF, Kerwin E, Sethi S, Haumann B, Pendyala S, Dean L, Barnes CN, Moran EJ, Crater G. Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease. Respir Med. 2019 Jul;153:38-43. doi: 10.1016/j.rmed.2019.05.010. Epub 2019 May 23.

Drugs

Indications