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A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

COPD

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

TD-4208

Placebo

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Upstate Pharmaceutical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

44 mcg

88 mcg

175 mcg

350 mcg

Arm Description

Placebo

TD-4208

Outcomes

Primary Outcome Measures

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)

Secondary Outcome Measures

Full Information

NCT ID

NCT02040792

First Posted

January 16, 2014

Last Updated

February 22, 2022

Sponsor

Mylan Inc.

Collaborators

Theravance Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT02040792

Brief Title

A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

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 Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

August 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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD

Keywords

COPD, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

355 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

44 mcg

Arm Type

Experimental

Arm Description

TD-4208

Arm Title

88 mcg

Arm Type

Experimental

Arm Description

TD-4208

Arm Title

175 mcg

Arm Type

Experimental

Arm Description

TD-4208

Arm Title

350 mcg

Arm Type

Experimental

Arm Description

TD-4208

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

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)

Time Frame

Baseline to 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medial Monitor

Organizational Affiliation

Theravance Biopharma

Official's Role

Study Director

Facility Information:

Facility Name

Upstate Pharmaceutical Research

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33124005

Citation

Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3.

Results Reference

derived

PubMed Identifier

29096627

Citation

Pudi KK, Barnes CN, Moran EJ, Haumann B, Kerwin E. A 28-day, randomized, double-blind, placebo-controlled, parallel group study of nebulized revefenacin in patients with chronic obstructive pulmonary disease. Respir Res. 2017 Nov 2;18(1):182. doi: 10.1186/s12931-017-0647-1.

Results Reference

derived

Learn more about this trial

A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

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