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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: NCT02512510
Recruitment Status : Completed
First Posted : July 31, 2015
Results First Posted : December 31, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 611 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

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



Primary Outcome Measures :
  1. Change From Baseline in Trough FEV1 on Day 85 [ Time Frame: Baseline and 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. St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85 [ Time Frame: Day 85 ]
    A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units

  5. Percentage of Albuterol Rescue-free 24-hour Periods [ Time Frame: 1-3 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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): NCT02512510


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
Theravance Biopharma
Investigators
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Study Director: Medical Monitor Theravance Biopharma

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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT02512510    
Other Study ID Numbers: 0127
First Posted: July 31, 2015    Key Record Dates
Results First Posted: December 31, 2018
Last Update Posted: February 19, 2019
Last Verified: January 2019
Keywords provided by Theravance Biopharma:
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