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A 52-Week Parallel Group Safety 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: NCT02518139
Recruitment Status : Completed
First Posted : August 7, 2015
Results First Posted : December 31, 2018
Last Update Posted : May 7, 2021
Sponsor:
Collaborator:
Theravance Biopharma
Information provided by (Responsible Party):
Mylan Inc.

Tracking Information
First Submitted Date  ICMJE August 5, 2015
First Posted Date  ICMJE August 7, 2015
Results First Submitted Date  ICMJE December 6, 2018
Results First Posted Date  ICMJE December 31, 2018
Last Update Posted Date May 7, 2021
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2015)
Pulmonary function test following 52 weeks of treatment [ Time Frame: 12 month pulmonary function test ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Drug: TD-4208
    Subjects receiving TD-4208 are blinded to one of two doses of 4208.
    Other Name: revefenacin
  • Drug: Tiotropium
    There is not a placebo, there is an active comparator (Tiotropium) arm.
Study Arms  ICMJE
  • Experimental: TD-4208-1
    88 mcg
    Intervention: Drug: TD-4208
  • Experimental: TD-4208-2
    175 mcg
    Intervention: Drug: TD-4208
  • Active Comparator: Tiotropium
    18 mcg
    Intervention: Drug: Tiotropium
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2019)
1060
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2015)
1050
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02518139
Other Study ID Numbers  ICMJE 0128
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mylan Inc.
Study Sponsor  ICMJE Mylan Inc.
Collaborators  ICMJE Theravance Biopharma
Investigators  ICMJE
Study Director: Medical Monitor Theravance Biopharma
PRS Account Mylan Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP