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A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) 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: NCT02109172
Recruitment Status : Completed
First Posted : April 9, 2014
Results First Posted : December 8, 2016
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:
This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design to patients with moderate to severe chronic obstructive pulmonary disease.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease COPD Drug: TD-4208 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Cross-Over Study of QD and BID Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Study Start Date : April 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

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
Experimental: TD-4208 44 mcg twice daily
TD-4208 inhalation solution 44 mcg twice daily for 7 days
 Drug: TD-4208
Other Name: Revefenacin
Placebo Comparator: Placebo
Placebo inhalation solution twice daily for 7 days
 Drug: Placebo
Experimental: TD-4208 175 mcg once daily
TD-4208 inhalation solution 175 mcg once daily, placebo once daily
 Drug: TD-4208
Other Name: Revefenacin

Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second) [ Time Frame: Following the Day 7 AM dose -12 hours post-dose and 24 hours post-dose ]
    Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline.


Eligibility Criteria
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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 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 (forced expiratory volume in 1 second/forced vital capacity) ratio <0.7
  • Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the Global Initiative for the Treatment of Obstructive Lung Disease (GOLD) Guidelines)
  • Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
  • Subject demonstrates a post-ipratropium FEV1 response ≥ 12% and ≥ 200 mL of pre-ipratropium FEV1 response
  • 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 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)
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): NCT02109172


Locations
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United States, North Carolina
American Health Research
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Mylan Inc.
Theravance Biopharma
Investigators
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Study Director: Medical Monitor Theravance Biopharma, US, Inc.
More Information
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Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT02109172    
Other Study ID Numbers: 0116
First Posted: April 9, 2014    Key Record Dates
Results First Posted: December 8, 2016
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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