NCT02518139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,060

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 31, 2018

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

1.8 years

First QC Date

August 5, 2015

Results QC Date

December 6, 2018

Last Update Submit

February 22, 2022

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease, COPD

Outcome Measures

Primary Outcomes (1)

  • 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)

    Baseline to Day 365

Study Arms (3)

TD-4208-1

EXPERIMENTAL

88 mcg

Drug: TD-4208

TD-4208-2

EXPERIMENTAL

175 mcg

Drug: TD-4208

Tiotropium

ACTIVE COMPARATOR

18 mcg

Drug: Tiotropium

Interventions

TD-4208DRUG

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

Also known as: revefenacin
TD-4208-1TD-4208-2
TiotropiumDRUG

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

Tiotropium

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is a male or female subject 40 years of age or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palmetto Medical Research Associates L.L.C

Easley, South Carolina, 29640, United States

Location

Related Publications (4)

  • Ohar JA, Mahler DA, Davis GN, Lombardi DA, Moran EJ, Crater GD. Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow. Can Respir J. 2024 Mar 22;2024:8034923. doi: 10.1155/2024/8034923. eCollection 2024.

    PMID: 38560416DERIVED

  • 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.

    PMID: 32343967DERIVED

  • Donohue JF, Kerwin E, Sethi S, Haumann B, Pendyala S, Dean L, Barnes CN, Moran EJ, Crater G. Maintained therapeutic effect of revefenacin over 52 weeks in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). Respir Res. 2019 Oct 30;20(1):241. doi: 10.1186/s12931-019-1187-7.

    PMID: 31666076DERIVED

  • 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.

    PMID: 31150963DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

revefenacinTiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Results Point of Contact

Title
Head of Clinical Development & Medical Affairs
Organization
Theravance Biopharma
medinfo@theravance.com
1-855-633-8479

Study Officials

  • Medical Monitor

    Theravance Biopharma

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 7, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

February 24, 2022

Results First Posted

December 31, 2018

Record last verified: 2022-02

Locations

US(1)