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

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ClinicalTrials.gov Identifier: NCT02518139

Recruitment Status : Completed

First Posted : August 7, 2015

Results First Posted : December 31, 2018

Last Update Posted : February 24, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Theravance Biopharma

Information provided by (Responsible Party):

Viatris Inc. ( Mylan Inc. )

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: TD-4208 Drug: Tiotropium	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1060 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A Phase 3, 52-week, Randomized, Active-Controlled Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Actual Study Start Date :	September 2015
Actual Primary Completion Date :	June 2017
Actual Study Completion Date :	June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Drug Information available for: Tiotropium bromide

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: TD-4208-1 88 mcg	Drug: TD-4208 Subjects receiving TD-4208 are blinded to one of two doses of 4208. Other Name: revefenacin
Experimental: TD-4208-2 175 mcg	Drug: TD-4208 Subjects receiving TD-4208 are blinded to one of two doses of 4208. Other Name: revefenacin
Active Comparator: Tiotropium 18 mcg	Drug: Tiotropium There is not a placebo, there is an active comparator (Tiotropium) arm.

Outcome Measures

Primary Outcome Measures :

Adverse Events: Frequency and Severity [ Time Frame: Baseline to Day 365 ]
To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is a male or female subject 40 years of age or older

Exclusion Criteria:

Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518139

Locations

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United States, South Carolina
Palmetto Medical Research Associates L.L.C
Easley, South Carolina, United States, 29640

Sponsors and Collaborators

Mylan Inc.

Theravance Biopharma

Investigators

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Study Director:	Medical Monitor	Theravance Biopharma

Study Documents (Full-Text)

Documents provided by Viatris Inc. ( Mylan Inc. ):

Study Protocol [PDF] January 21, 2016

Statistical Analysis Plan [PDF] March 13, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. 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.

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Responsible Party:	Mylan Inc.
ClinicalTrials.gov Identifier:	NCT02518139
Other Study ID Numbers:	0128
First Posted:	August 7, 2015 Key Record Dates
Results First Posted:	December 31, 2018
Last Update Posted:	February 24, 2022
Last Verified:	February 2022

Keywords provided by Viatris Inc. ( Mylan Inc. ):


Chronic Obstructive Pulmonary Disease, COPD

Additional relevant MeSH terms:

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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Chronic Disease Disease Attributes Pathologic Processes Tiotropium Bromide Bronchodilator Agents Autonomic Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Parasympatholytics Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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