NCT02459080

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
619

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_3

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

May 22, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2.3 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

11 months

First QC Date

May 22, 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)

  • Change From Baseline in Trough FEV1 on Day 85

    Day 85

Secondary Outcomes (5)

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

    Days 15 to 85

  • Summary of Change From Baseline to Peak FEV1 After First Dose

    0-2 hours after First Dose Day 1

  • Summary of Rescue Medication Use: Puffs Per Day

    1-3 Months

  • Percentage of Albuterol Rescue-free 24-hour Periods

    1-3 Months

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

    Baseline to Day 85

Study Arms (3)

TD-4208-1

ACTIVE COMPARATOR

88 mcg

Drug: TD-4208

TD-4208-2

ACTIVE COMPARATOR

175 mcg

Drug: TD-4208

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

TD-4208DRUG
Also known as: revefenacin
TD-4208-1TD-4208-2
PlaceboDRUG
Placebo

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)

Allergy Associates Research Center (AARC)

Portland, Oregon, 97202, United States

Location

Related Publications (3)

  • Donohue JF, Ferguson GT, Ohar JA, Lombardi DA, Schneider RF, Johnson K. Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease. Respir Med. 2023 Mar;208:107123. doi: 10.1016/j.rmed.2023.107123. Epub 2023 Jan 18.

    PMID: 36681255DERIVED

  • 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.

    PMID: 33124005DERIVED

  • 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.

    PMID: 32393215DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

revefenacin

Condition Hierarchy (Ancestors)

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

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

May 22, 2015

First Posted

June 1, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

February 24, 2022

Results First Posted

December 31, 2018

Record last verified: 2022-02

Locations

US(1)