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TD-4208

DRUG9 trials

Sponsors

Mylan Inc.

Conditions

COPDChronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary Disease (COPD)Hepatic ImpairmentRenal Impairment

Phase 1

Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment
CompletedNCT02578082
Mylan Inc.Renal Impairment
Start: 2015-12-31End: 2016-05-31Updated: 2022-02-24
Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment
CompletedNCT02581592
Mylan Inc.Hepatic Impairment
Start: 2015-11-30End: 2016-04-30Updated: 2022-02-24
TD-4208 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects
CompletedNCT02772159
Mylan Inc.Chronic Obstructive Pulmonary Disease (COPD)
Start: 2015-06-30End: 2016-04-30Updated: 2022-02-24

Phase 2

7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
CompletedNCT01704404
Mylan Inc.COPD
Start: 2012-12-31End: 2013-12-31Updated: 2022-02-24
A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
CompletedNCT02040792
Mylan Inc.COPD
Start: 2014-05-31End: 2014-08-31Updated: 2022-02-24
A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
CompletedNCT02109172
Mylan Inc.Chronic Obstructive Pulmonary Disease, COPD
Start: 2014-04-30End: 2014-10-31Updated: 2022-02-24

Phase 3

Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
CompletedNCT02459080
Mylan Inc.Chronic Obstructive Pulmonary Disease (COPD)
Start: 2015-09-30End: 2016-09-30Updated: 2022-02-24
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
CompletedNCT02512510
Mylan Inc.Chronic Obstructive Pulmonary Disease (COPD)
Start: 2015-09-30End: 2016-09-30Updated: 2022-02-24
A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
CompletedNCT02518139
Mylan Inc.Chronic Obstructive Pulmonary Disease (COPD)
Start: 2015-09-30End: 2017-06-30Updated: 2022-02-24

Related Papers

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Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow
Canadian Respiratory Journal2024-03-224 citations
Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease
Respiratory Medicine2023-01-18
Improvements in Lung Function with Revefenacin for Nebulization in Women vs Men with Moderate to Very Severe Chronic Obstructive Pulmonary Disease: Subgroup Analyses from Phase 3 Clinical Trials
2021-05-01
Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease
Clinical Pharmacokinetics2020-10-291 citations
Efficacy of revefenacin, a long-acting muscarinic antagonist for nebulized therapy, in patients with markers of more severe COPD: a post hoc subgroup analysis
BMC Pulmonary Medicine2020-05-115 citations
Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers.
2020-04-2512 citations
Efficacy and safety of revefenacin for nebulization in patients with chronic obstructive pulmonary disease taking concomitant ICS/LABA or LABA: subgroup analysis from phase III trials
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Maintained therapeutic effect of revefenacin over 52 weeks in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD).
2019-10-3011 citations
Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function.
2019-10-085 citations
Efficacy of revefenacin based on GOLD 2017 categories: reanalysis of phase 3 data in patients with COPD
2019-09-28
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.
2019-05-2323 citations
A 28-day, randomized, double-blind, placebo-controlled, parallel group study of nebulized revefenacin in patients with chronic obstructive pulmonary disease.
2017-11-0223 citations
Efficacy and safety of revefenacin (REV), a long-acting muscarinic antagonist for nebulization: results of replicate randomized, double-blind, placebo-controlled, parallel-group phase 3 trials in participants with moderate to very severe COPD
2017-09-01