NCT02040792

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
355

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2014

Shorter than P25 for phase_2

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

January 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

December 7, 2016

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

January 16, 2014

Results QC Date

June 30, 2016

Last Update Submit

February 22, 2022

Conditions

COPD

Keywords

COPDChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

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

    Baseline to 28 days

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

44 mcg

EXPERIMENTAL

TD-4208

Drug: TD-4208

88 mcg

EXPERIMENTAL

TD-4208

Drug: TD-4208

175 mcg

EXPERIMENTAL

TD-4208

Drug: TD-4208

350 mcg

EXPERIMENTAL

TD-4208

Drug: TD-4208

Interventions

TD-4208DRUG
Also known as: revefenacin
175 mcg350 mcg44 mcg88 mcg
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
  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Upstate Pharmaceutical Research

Greenville, South Carolina, 29615, United States

Location

Related Publications (2)

  • 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

  • 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.

    PMID: 29096627DERIVED

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

  • Medial 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 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 20, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2014

Study Completion

August 1, 2014

Last Updated

February 24, 2022

Results First Posted

December 7, 2016

Record last verified: 2022-02

Locations

US(1)