CompletedNCT02040792Updated Feb 24, 2022Results posted

A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 interventional study of TD-4208 and Placebo in COPD, sponsored by Mylan Inc.. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-02-24.

Sponsored by Mylan Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 355
Allocation: Randomized
Ages: 40 Years and older
Sex: All

Study 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.

Conditions studied

COPD

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Keywords

COPD
Chronic Obstructive Pulmonary Disease

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 355 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Mylan Inc. is the lead sponsor of 43 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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)

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 355 participants (actual)

Study arms

Placebo comparator
Placebo
Placebo
Drug: Placebo
Experimental
44 mcg
TD-4208
Drug: TD-4208
Experimental
88 mcg
TD-4208
Drug: TD-4208
Experimental
175 mcg
TD-4208
Drug: TD-4208
Experimental
350 mcg
TD-4208
Drug: TD-4208

Interventions

DrugTD-4208
Also known as: revefenacin
DrugPlacebo

What researchers measure

Primary outcomes

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)
Time frame: Baseline to 28 days

Results

Posted Dec 7, 2016

Participant flow

Participant flow — Overall Study
Milestone	Placebo	44 mcg	88 mcg	175 mcg	350 mcg
Started	70	68	71	71	74
Completed	64	65	68	64	67
Not completed	6	3	3	7	7

Outcome measures

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

Time frame:: Baseline to 28 days
Reported as:: Least squares mean · mL

Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)
mL	Placebo	44 mcg	88 mcg	175 mcg	350 mcg
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)	-32.4 ± 25.36	19.4 ± 24.98	155.0 ± 24.61	134.2 ± 25.07	138.2 ± 24.38

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	0/71 (0%)	8/71 (11.3%)
44 mcg	—	1/68 (1.5%)	1/68 (1.5%)
88 mcg	—	0/71 (0%)	6/71 (8.5%)
175 mcg	—	2/71 (2.8%)	10/71 (14.1%)
350 mcg	—	1/74 (1.4%)	15/74 (20.3%)

Most frequent serious events

Most frequent serious events
Event	Placebo	44 mcg	88 mcg	175 mcg	350 mcg
Supraventricular tachycardiaCardiac disorders	0/71	1/68	0/71	0/71	0/74
Angina UnstableCardiac disorders	0/71	0/68	0/71	1/71	0/74
HypertensionVascular disorders	0/71	0/68	0/71	1/71	0/74
Intestinal ObstructionGastrointestinal disorders	0/71	0/68	0/71	0/71	1/74

Most frequent other events

Most frequent other events
Event	Placebo	44 mcg	88 mcg	175 mcg	350 mcg
HeadacheGeneral disorders	2/71	1/68	2/71	1/71	5/74
DyspneaRespiratory, thoracic and mediastinal disorders	2/71	0/68	3/71	3/71	2/74
CoughRespiratory, thoracic and mediastinal disorders	1/71	0/68	0/71	3/71	3/74
COPDRespiratory, thoracic and mediastinal disorders	2/71	0/68	0/71	1/71	2/74
Back painMusculoskeletal and connective tissue disorders	0/71	0/68	1/71	2/71	1/74
Oropharyngeal painGeneral disorders	1/71	1/68	0/71	0/71	2/74

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo	44 mcg	88 mcg	175 mcg	350 mcg	Total
Mean	62.2 ± 9.17	60.9 ± 8.87	60.4 ± 7.98	64.5 ± 7.69	61.4 ± 8.98	61.9 ± 8.63

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	44 mcg	88 mcg	175 mcg	350 mcg	Total
Female	33	36	39	34	34	176
Male	37	32	32	37	40	178

Study locations

1 site

Upstate Pharmaceutical Research
Greenville, South Carolina 29615, United States

References and documents

Publications

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. PubMed 33124005 ↗
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. PubMed 29096627 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02040792
Lead sponsor: Mylan Inc.
Collaborators: Theravance Biopharma
Responsible party: Sponsor
First posted: Jan 20, 2014
Start date: May 2014
Primary completion: Jul 2014
Completion: Aug 2014
Results posted: Dec 7, 2016
Last update: Feb 24, 2022

Study contacts

Medial Monitor

study director · Theravance Biopharma

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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