A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease, COPD
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TD-4208
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, COPD
Eligibility 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)
Sites / Locations
- American Health Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
TD-4208 44 mcg twice daily
Placebo
TD-4208 175 mcg once daily
Arm Description
TD-4208 inhalation solution 44 mcg twice daily for 7 days
Placebo inhalation solution twice daily for 7 days
TD-4208 inhalation solution 175 mcg once daily, placebo once daily
Outcomes
Primary Outcome Measures
Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second)
Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline.
Secondary Outcome Measures
Full Information
NCT ID
NCT02109172
First Posted
April 6, 2014
Last Updated
February 22, 2022
Sponsor
Mylan Inc.
Collaborators
Theravance Biopharma
1. Study Identification
Unique Protocol Identification Number
NCT02109172
Brief Title
A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Inc.
Collaborators
Theravance Biopharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD
Keywords
Chronic Obstructive Pulmonary Disease, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TD-4208 44 mcg twice daily
Arm Type
Experimental
Arm Description
TD-4208 inhalation solution 44 mcg twice daily for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo inhalation solution twice daily for 7 days
Arm Title
TD-4208 175 mcg once daily
Arm Type
Experimental
Arm Description
TD-4208 inhalation solution 175 mcg once daily, placebo once daily
Intervention Type
Drug
Intervention Name(s)
TD-4208
Other Intervention Name(s)
Revefenacin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second)
Description
Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline.
Time Frame
Following the Day 7 AM dose -12 hours post-dose and 24 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma, US, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
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