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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
Theravance Biopharma
Information provided by (Responsible Party):
Viatris Inc. ( Mylan Inc. )

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

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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

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.

Primary Outcome Measures :
  1. 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)

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

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

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

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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
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action