FindTrial
Sign In

Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02512510
Acronym
COPD
Enrollment
611
Registered
2015-07-31
Start date
2015-09-30
Completion date
2016-09-30
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 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.

Interventions

DRUGTD-4208
DRUGPlacebo

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 frame
Change From Baseline in Trough FEV1 on Day 85Baseline and Day 85

Secondary

MeasureTime frameDescription
Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85Days 15 to 85—
Summary of Change From Baseline to Peak FEV1 After First Dose0-2 hours after First Dose Day 1—
Summary of Rescue Medication Use: Puffs Per Day1-3 Months—
St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85Day 85A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units
Percentage of Albuterol Rescue-free 24-hour Periods1-3 Months—

Countries

United States

Participant flow

Participants by arm

ArmCount
TD-4208-1
88 mcg TD-4208
205
TD-4208-2
175 mcg TD-4208
197
Placebo
Placebo Placebo
208
Total610

Baseline characteristics

CharacteristicTD-4208-1TD-4208-2PlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
84 Participants91 Participants93 Participants268 Participants
Age, Categorical
Between 18 and 65 years
121 Participants106 Participants115 Participants342 Participants
Age, Continuous63.1 years
STANDARD_DEVIATION 8.81
63.6 years
STANDARD_DEVIATION 9.19
63.5 years
STANDARD_DEVIATION 8.91
63.4 years
STANDARD_DEVIATION 8.95
Ethnicity (NIH/OMB)
Hispanic or Latino
17 Participants10 Participants12 Participants39 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
188 Participants186 Participants194 Participants568 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants2 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants0 Participants3 Participants
Race (NIH/OMB)
Black or African American
17 Participants21 Participants20 Participants58 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
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
186 Participants171 Participants188 Participants545 Participants
Region of Enrollment
United States
205 participants197 participants208 participants610 participants
Sex: Female, Male
Female
102 Participants95 Participants111 Participants308 Participants
Sex: Female, Male
Male
103 Participants102 Participants97 Participants302 Participants
Smoking Status
Current Smoker
97 Participants94 Participants95 Participants286 Participants
Smoking Status
Former Smoker
108 Participants103 Participants113 Participants324 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 2051 / 1970 / 209
other
Total, other adverse events
59 / 20562 / 19752 / 209
serious
Total, serious adverse events
11 / 2055 / 1977 / 209

Outcome results

Primary

Change From Baseline in Trough FEV1 on Day 85

Time frame: Baseline and Day 85

Population: Intent-to-treat (ITT) analysis set

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
TD-4208-1Change From Baseline in Trough FEV1 on Day 85115.58 mLStandard Error 18.637
TD-4208-2Change From Baseline in Trough FEV1 on Day 85102.90 mLStandard Error 18.542
PlaceboChange From Baseline in Trough FEV1 on Day 85-44.92 mLStandard Error 18.841
Secondary

Percentage of Albuterol Rescue-free 24-hour Periods

Time frame: 1-3 Months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
TD-4208-1Percentage of Albuterol Rescue-free 24-hour Periods44.79 Percentage of 24hr periodsStandard Error 2.8
TD-4208-2Percentage of Albuterol Rescue-free 24-hour Periods43.26 Percentage of 24hr periodsStandard Error 2.769
PlaceboPercentage of Albuterol Rescue-free 24-hour Periods37.23 Percentage of 24hr periodsStandard Error 2.766
Secondary

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

A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units

Time frame: Day 85

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TD-4208-1St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 8567 Participants
TD-4208-2St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 8567 Participants
PlaceboSt. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 8554 Participants
Secondary

Summary of Change From Baseline to Peak FEV1 After First Dose

Time frame: 0-2 hours after First Dose Day 1

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
TD-4208-1Summary of Change From Baseline to Peak FEV1 After First Dose218.65 mLStandard Error 10.291
TD-4208-2Summary of Change From Baseline to Peak FEV1 After First Dose216.84 mLStandard Error 10.248
PlaceboSummary of Change From Baseline to Peak FEV1 After First Dose88.22 mLStandard Error 10.092
Secondary

Summary of Rescue Medication Use: Puffs Per Day

Time frame: 1-3 Months

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
TD-4208-1Summary of Rescue Medication Use: Puffs Per Day2.00 Puffs per DayStandard Error 0.207
TD-4208-2Summary of Rescue Medication Use: Puffs Per Day2.38 Puffs per DayStandard Error 0.204
PlaceboSummary of Rescue Medication Use: Puffs Per Day2.54 Puffs per DayStandard Error 0.206
Secondary

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

Time frame: Days 15 to 85

ArmMeasureValue (MEAN)Dispersion
TD-4208-1Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 8583.9 mLStandard Error 3.14
TD-4208-2Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 8587.1 mLStandard Error 3.21
PlaceboSummary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85-39.9 mLStandard Error 3.15

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026