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A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (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: NCT02040792
Recruitment Status : Completed
First Posted : January 20, 2014
Results First Posted : December 7, 2016
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Brief Summary:
This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product when administered once daily for 28 days using a jet nebulizer to patients with moderate to severe chronic obstructive pulmonary disease.

Condition or disease Intervention/treatment Phase
COPD Drug: TD-4208 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2B, 28-Day, Randomized, Double-Blind Placebo-Controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Study Start Date : May 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Experimental: 44 mcg
TD-4208
Drug: TD-4208
Other Name: revefenacin

Experimental: 88 mcg
TD-4208
Drug: TD-4208
Other Name: revefenacin

Experimental: 175 mcg
TD-4208
Drug: TD-4208
Other Name: revefenacin

Experimental: 350 mcg
TD-4208
Drug: TD-4208
Other Name: revefenacin




Primary Outcome Measures :
  1. Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second) [ Time Frame: Baseline to 28 days ]


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
  • Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
  • Subject is capable of performing reproducible spirometry maneuvers
  • Subject has post-bronchodilator FEV1/FVC ratio <0.7
  • Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)
  • Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
  • Subject has a current or past smoking history of at least 10 pack-years.

Exclusion Criteria:

  • Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
  • Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents
  • Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
  • Subject has been hospitalized for COPD or pneumonia within 12 weeks
  • Subject requires long-term oxygen therapy (>15 hours a day)

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): NCT02040792


Locations
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United States, South Carolina
Upstate Pharmaceutical Research
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Medial Monitor Theravance Biopharma
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT02040792    
Other Study ID Numbers: 0117
First Posted: January 20, 2014    Key Record Dates
Results First Posted: December 7, 2016
Last Update Posted: December 2, 2019
Last Verified: November 2019
Keywords provided by Theravance Biopharma:
COPD
Chronic Obstructive Pulmonary Disease
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases