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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 19, 2019
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Tracking Information
First Submitted Date  ICMJE May 22, 2015
First Posted Date  ICMJE June 1, 2015
Results First Submitted Date  ICMJE December 6, 2018
Results First Posted Date  ICMJE December 31, 2018
Last Update Posted Date February 19, 2019
Study Start Date  ICMJE September 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
Change From Baseline in Trough FEV1 on Day 85 [ Time Frame: Day 85 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2015)
Pulmonary function test following 12 weeks of treatment [ Time Frame: 3 month pulmonary function test ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2019)
  • Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85 [ Time Frame: Days 15 to 85 ]
  • Summary of Change From Baseline to Peak FEV1 After First Dose [ Time Frame: 0-2 hours after First Dose Day 1 ]
  • Summary of Rescue Medication Use: Puffs Per Day [ Time Frame: 1-3 Months ]
  • Percentage of Albuterol Rescue-free 24-hour Periods [ Time Frame: 1-3 Months ]
  • 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
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 Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
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.
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
    Other Name: revefenacin
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: TD-4208-1
    88 mcg
    Intervention: Drug: TD-4208
  • Active Comparator: TD-4208-2
    175 mcg
    Intervention: Drug: TD-4208
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Donohue JF, Kerwin E, Barnes CN, Moran EJ, Haumann B, Crater GD. Efficacy of revefenacin, a long-acting muscarinic antagonist for nebulized therapy, in patients with markers of more severe COPD: a post hoc subgroup analysis. BMC Pulm Med. 2020 May 11;20(1):134. doi: 10.1186/s12890-020-1156-4.

*   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: June 6, 2016)
619
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date August 2016   (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 NCT02459080
Other Study ID Numbers  ICMJE 0126
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Theravance Biopharma
Study Sponsor  ICMJE Theravance Biopharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Theravance Biopharma
PRS Account Theravance Biopharma
Verification Date January 2019

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