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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
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

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 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1080 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
Active Comparator: TD-4208-1
88 mcg
Drug: TD-4208
There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium.
Other Name: revefenacin

Active Comparator: TD-4208-2
175 mcg
Drug: TD-4208
There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium.
Other Name: revefenacin

Active Comparator: Tiotropium
18 mcg
Drug: TD-4208
There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium.
Other Name: revefenacin




Primary Outcome Measures :
  1. Pulmonary function test following 52 weeks of treatment [ Time Frame: 12 month pulmonary function test ]


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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

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
United States, South Carolina
Palmetto Medical Research Associates L.L.C
Easley, South Carolina, United States, 29640
Sponsors and Collaborators
Theravance Biopharma
Investigators
Study Director: Srikanth Pendyala, MD Theravance Biopharma

Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT02518139     History of Changes
Other Study ID Numbers: 0128
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Theravance Biopharma:
Chronic Obstructive Pulmonary Disease, COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases