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Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

TD-4208

Placebo

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

Active Comparator

Placebo Comparator

Arm Label

TD-4208-1

TD-4208-2

Placebo

Arm Description

88 mcg

175 mcg

Placebo

Outcomes

Primary Outcome Measures

Change From Baseline in Trough FEV1 on Day 85

Secondary Outcome Measures

Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85

Summary of Change From Baseline to Peak FEV1 After First Dose

Summary of Rescue Medication Use: Puffs Per Day

St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85

A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units

Percentage of Albuterol Rescue-free 24-hour Periods

Full Information

NCT ID

NCT02512510

First Posted

July 28, 2015

Last Updated

February 22, 2022

Sponsor

Mylan Inc.

Collaborators

Theravance Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT02512510

Brief Title

Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)

Acronym

COPD

Official Title

A Phase 3, 12-week, 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

September 2015 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

September 2016 (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 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.

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

611 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TD-4208-1

Arm Type

Active Comparator

Arm Description

88 mcg

Arm Title

TD-4208-2

Arm Type

Active Comparator

Arm Description

175 mcg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

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 on Day 85

Time Frame

Baseline and Day 85

Secondary Outcome Measure Information:

Title

Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85

Time Frame

Days 15 to 85

Title

Summary of Change From Baseline to Peak FEV1 After First Dose

Time Frame

0-2 hours after First Dose Day 1

Title

Summary of Rescue Medication Use: Puffs Per Day

Time Frame

1-3 Months

Title

St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85

Description

A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units

Time Frame

Day 85

Title

Percentage of Albuterol Rescue-free 24-hour Periods

Time Frame

1-3 Months

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

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

32393215

Citation

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.

Results Reference

derived

Learn more about this trial

Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)

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