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A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

TD-4208

Tiotropium

About this trial

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

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

Exclusion Criteria:

Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

Sites / Locations

Palmetto Medical Research Associates L.L.C

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

TD-4208-1

TD-4208-2

Tiotropium

Arm Description

88 mcg

175 mcg

18 mcg

Outcomes

Primary Outcome Measures

Adverse Events: Frequency and Severity

To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE)

Secondary Outcome Measures

Full Information

NCT ID

NCT02518139

First Posted

August 5, 2015

Last Updated

February 22, 2022

Sponsor

Mylan Inc.

Collaborators

Theravance Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT02518139

Brief Title

A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

September 2015 (Actual)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

June 2017 (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

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.

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 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1060 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TD-4208-1

Arm Type

Experimental

Arm Description

88 mcg

Arm Title

TD-4208-2

Arm Type

Experimental

Arm Description

175 mcg

Arm Title

Tiotropium

Arm Type

Active Comparator

Arm Description

18 mcg

Intervention Type

Drug

Intervention Name(s)

TD-4208

Other Intervention Name(s)

revefenacin

Intervention Description

Subjects receiving TD-4208 are blinded to one of two doses of 4208.

Intervention Type

Drug

Intervention Name(s)

Tiotropium

Intervention Description

There is not a placebo, there is an active comparator (Tiotropium) arm.

Primary Outcome Measure Information:

Title

Adverse Events: Frequency and Severity

Description

To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE)

Time Frame

Baseline to Day 365

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 Exclusion Criteria: Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Theravance Biopharma

Official's Role

Study Director

Facility Information:

Facility Name

Palmetto Medical Research Associates L.L.C

City

Easley

State/Province

South Carolina

ZIP/Postal Code

29640

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32343967

Citation

Barnes CN, Mahler DA, Ohar JA, Lombardi DA, Crater GD. Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers. Chest. 2020 Oct;158(4):1413-1419. doi: 10.1016/j.chest.2020.03.072. Epub 2020 Apr 25.

Results Reference

derived

PubMed Identifier

31150963

Citation

Donohue JF, Kerwin E, Sethi S, Haumann B, Pendyala S, Dean L, Barnes CN, Moran EJ, Crater G. Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease. Respir Med. 2019 Jul;153:38-43. doi: 10.1016/j.rmed.2019.05.010. Epub 2019 May 23.

Results Reference

derived

Learn more about this trial

A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

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