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Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02459080
Recruitment Status : Completed
First Posted : June 1, 2015
Results First Posted : December 31, 2018
Last Update Posted : February 24, 2022
Sponsor:
Collaborator:
Theravance Biopharma
Information provided by (Responsible Party):
Viatris Inc. ( Mylan Inc. )

Study Description
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Brief Summary:
The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 619 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Study Start Date : September 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: TD-4208-1
88 mcg
 Drug: TD-4208
Other Name: revefenacin
Active Comparator: TD-4208-2
175 mcg
 Drug: TD-4208
Other Name: revefenacin
Placebo Comparator: Placebo
Placebo
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Trough FEV1 on Day 85 [ Time Frame: Day 85 ]

Secondary Outcome Measures :
  1. Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85 [ Time Frame: Days 15 to 85 ]
  2. Summary of Change From Baseline to Peak FEV1 After First Dose [ Time Frame: 0-2 hours after First Dose Day 1 ]
  3. Summary of Rescue Medication Use: Puffs Per Day [ Time Frame: 1-3 Months ]
  4. Percentage of Albuterol Rescue-free 24-hour Periods [ Time Frame: 1-3 Months ]
  5. St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85 [ Time Frame: Baseline to Day 85 ]
    A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units


Eligibility Criteria
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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
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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): NCT02459080


Locations
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United States, Oregon
Allergy Associates Research Center (AARC)
Portland, Oregon, United States, 97202
Sponsors and Collaborators
Mylan Inc.
Theravance Biopharma
Investigators
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Study Director: Medical Monitor Theravance Biopharma
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT02459080    
Other Study ID Numbers: 0126
First Posted: June 1, 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