CompletedNCT02518139Updated Feb 24, 2022Results posted

A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 interventional study of TD-4208 and Tiotropium in Chronic Obstructive Pulmonary Disease (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 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,060
Allocation: Randomized
Ages: 40 Years and older
Sex: All

Study 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.

Conditions studied

Chronic Obstructive Pulmonary Disease (COPD)

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Keywords

Chronic Obstructive Pulmonary Disease, COPD

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 1,060 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

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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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 1,060 participants (actual)

Study arms

Experimental
TD-4208-1
88 mcg
Drug: TD-4208
Experimental
TD-4208-2
175 mcg
Drug: TD-4208
Active comparator
Tiotropium
18 mcg
Drug: Tiotropium

Interventions

DrugTD-4208
Subjects receiving TD-4208 are blinded to one of two doses of 4208.
Also known as: revefenacin
DrugTiotropium
There is not a placebo, there is an active comparator (Tiotropium) arm.

What researchers measure

Primary outcomes

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)
Time frame: Baseline to Day 365

Results

Posted Dec 31, 2018

Participant flow

Participant flow — Overall Study
Milestone	TD-4208-1	TD-4208-2	Tiotropium
Started	364	335	356
Completed	219	191	262
Not completed	145	144	94

Outcome measures

PrimaryAdverse 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)

Time frame:: Baseline to Day 365
Reported as:: Count of participants · Participants

Adverse Events: Frequency and Severity
Participants	TD-4208-1	TD-4208-2	Tiotropium
Adverse Event (AE)	272	242	275
Moderate or Severe AE	226	174	210
Serious AE	58	43	58

Adverse events

Collected over Adverse events were recorded from signing of the ICF through the final follow-up assessment (approximately 1 year). Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
TD-4208-1	1/364 (0.3%)	58/364 (15.9%)	202/364 (55.5%)
TD-4208-2	1/335 (0.3%)	43/335 (12.8%)	166/335 (49.6%)
Tiotropium	1/356 (0.3%)	58/356 (16.3%)	188/356 (52.8%)

Most frequent serious events

Showing 10 of 136

Most frequent serious events
Event	TD-4208-1	TD-4208-2	Tiotropium
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders	13/364	8/335	13/356
PneumoniaInfections and infestations	10/364	1/335	6/356
Myocardial infarctionCardiac disorders	4/364	2/335	0/356
Acute respiratory failureRespiratory, thoracic and mediastinal disorders	3/364	3/335	3/356
Acute myocardial infarctionCardiac disorders	1/364	3/335	2/356
Atrial fibrillationCardiac disorders	2/364	0/335	3/356
Non-cardiac chest painGeneral disorders	3/364	1/335	0/356
Angina unstableCardiac disorders	0/364	2/335	0/356
OsteoarthritisMusculoskeletal and connective tissue disorders	2/364	2/335	1/356
PneumothoraxRespiratory, thoracic and mediastinal disorders	0/364	1/335	2/356

Most frequent other events

Showing 10 of 16

Most frequent other events
Event	TD-4208-1	TD-4208-2	Tiotropium
Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders	107/364	73/335	100/356
DyspnoeaRespiratory, thoracic and mediastinal disorders	31/364	13/335	13/356
NasopharyngitisInfections and infestations	28/364	26/335	17/356
CoughRespiratory, thoracic and mediastinal disorders	18/364	25/335	20/356
Upper Respiratory Tract InfectionInfections and infestations	24/364	20/335	24/356
HeadacheNervous system disorders	15/364	13/335	20/356
Urinary tract infectionInfections and infestations	20/364	11/335	15/356
BronchitisInfections and infestations	17/364	17/335	9/356
HypertensionVascular disorders	18/364	8/335	16/356
PneumoniaRespiratory, thoracic and mediastinal disorders	16/364	5/335	14/356

Baseline characteristics

1060 subjects were randomized. A total of 1055 subjects received at least one dose of study drug.

Age, Categorical
Age, Categorical(Participants)	TD-4208-1	TD-4208-2	Tiotropium	Total
<=18 years	0	0	0	0
Between 18 and 65 years	183	167	163	513
>=65 years	181	168	193	542

Age, Continuous
Age, Continuous(years)	TD-4208-1	TD-4208-2	Tiotropium	Total
Mean	64.1 ± 9.36	64.4 ± 8.61	64.9 ± 8.91	64.4 ± 8.97

Sex: Female, Male
Sex: Female, Male(Participants)	TD-4208-1	TD-4208-2	Tiotropium	Total
Female	158	139	142	439
Male	206	196	214	616

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	TD-4208-1	TD-4208-2	Tiotropium	Total
Hispanic or Latino	6	5	3	14
Not Hispanic or Latino	357	326	352	1035
Unknown or Not Reported	1	4	1	6

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	TD-4208-1	TD-4208-2	Tiotropium	Total
American Indian or Alaska Native	0	0	0	0
Asian	1	2	1	4
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	24	21	24	69
White	337	309	331	977
More than one race	1	2	0	3
Unknown or Not Reported	1	1	0	2

Region of Enrollment
Region of Enrollment(participants)	TD-4208-1	TD-4208-2	Tiotropium	Total
United States	364	335	356	1055

Smoking Status
Smoking Status(Participants)	TD-4208-1	TD-4208-2	Tiotropium	Total
Current Smoker	171	151	167	489
Former Smoker	193	184	189	566

Study locations

1 site

Palmetto Medical Research Associates L.L.C
Easley, South Carolina 29640, United States

References and documents

Publications

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. PubMed 32343967 ↗
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. PubMed 31150963 ↗

Study documents

Study protocol · Jan 21, 2016
Statistical analysis plan · Mar 13, 2017

Documents are hosted by the registry — open the source record to download them.

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: NCT02518139
Lead sponsor: Mylan Inc.
Collaborators: Theravance Biopharma
Responsible party: Sponsor
First posted: Aug 7, 2015
Start date: Sep 2015
Primary completion: Jun 2017
Completion: Jun 2017
Results posted: Dec 31, 2018
Last update: Feb 24, 2022

Study contacts

Medical Monitor

study director · Theravance Biopharma

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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