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

A Phase 3, 52-week, Randomized, Active-Controlled Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02518139
Enrollment
1060
Registered
2015-08-07
Start date
2015-09-30
Completion date
2017-06-30
Last updated
2022-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease, COPD

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.

Interventions

DRUGTD-4208

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

DRUGTiotropium

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

Sponsors

Theravance Biopharma
CollaboratorINDUSTRY
Mylan Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Adverse Events: Frequency and SeverityBaseline to Day 365To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE)

Countries

United States

Participant flow

Participants by arm

ArmCount
TD-4208-1
88 mcg TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium.
364
TD-4208-2
175 mcg TD-4208: There is not a placebo, there is a comparator (Tiotropium) arm, and the subjects are blinded to one of two doses of 4208 or un-blinded to Tiotropium.
335
Tiotropium
18 mcg Tiotropium: Active comparator
356
Total1,055

Baseline characteristics

CharacteristicTD-4208-1TD-4208-2TiotropiumTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
181 Participants168 Participants193 Participants542 Participants
Age, Categorical
Between 18 and 65 years
183 Participants167 Participants163 Participants513 Participants
Age, Continuous64.1 years
STANDARD_DEVIATION 9.36
64.4 years
STANDARD_DEVIATION 8.61
64.9 years
STANDARD_DEVIATION 8.91
64.4 years
STANDARD_DEVIATION 8.97
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants5 Participants3 Participants14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
357 Participants326 Participants352 Participants1035 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants4 Participants1 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants1 Participants4 Participants
Race (NIH/OMB)
Black or African American
24 Participants21 Participants24 Participants69 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants0 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
White
337 Participants309 Participants331 Participants977 Participants
Region of Enrollment
United States
364 participants335 participants356 participants1055 participants
Sex: Female, Male
Female
158 Participants139 Participants142 Participants439 Participants
Sex: Female, Male
Male
206 Participants196 Participants214 Participants616 Participants
Smoking Status
Current Smoker
171 Participants151 Participants167 Participants489 Participants
Smoking Status
Former Smoker
193 Participants184 Participants189 Participants566 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
1 / 3641 / 3351 / 356
other
Total, other adverse events
202 / 364166 / 335188 / 356
serious
Total, serious adverse events
58 / 36443 / 33558 / 356

Outcome results

Primary

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
TD-4208-1Adverse Events: Frequency and SeveritySerious AE58 Participants
TD-4208-1Adverse Events: Frequency and SeverityModerate or Severe AE226 Participants
TD-4208-1Adverse Events: Frequency and SeverityAdverse Event (AE)272 Participants
TD-4208-2Adverse Events: Frequency and SeveritySerious AE43 Participants
TD-4208-2Adverse Events: Frequency and SeverityAdverse Event (AE)242 Participants
TD-4208-2Adverse Events: Frequency and SeverityModerate or Severe AE174 Participants
TiotropiumAdverse Events: Frequency and SeverityModerate or Severe AE210 Participants
TiotropiumAdverse Events: Frequency and SeverityAdverse Event (AE)275 Participants
TiotropiumAdverse Events: Frequency and SeveritySerious AE58 Participants

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026