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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
NCT02459080
Acronym
COPD
Enrollment
619
Registered
2015-06-01
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 85Day 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—
Percentage of Albuterol Rescue-free 24-hour Periods1-3 Months—
St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85Baseline to Day 85A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units

Countries

United States

Participant flow

Participants by arm

ArmCount
TD-4208-1
88 mcg TD-4208
212
TD-4208-2
175 mcg TD-4208
198
Placebo
Placebo Placebo
209
Total619

Baseline characteristics

CharacteristicTD-4208-1TD-4208-2PlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
100 Participants102 Participants105 Participants307 Participants
Age, Categorical
Between 18 and 65 years
112 Participants96 Participants104 Participants312 Participants
Age, Continuous63.7 years
STANDARD_DEVIATION 8.9
64.2 years
STANDARD_DEVIATION 8.6
64.3 years
STANDARD_DEVIATION 9.12
64.1 years
STANDARD_DEVIATION 8.87
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants6 Participants3 Participants13 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
205 Participants186 Participants204 Participants595 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants6 Participants2 Participants11 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants0 Participants3 Participants
Race (NIH/OMB)
Black or African American
16 Participants16 Participants17 Participants49 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants1 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
194 Participants179 Participants191 Participants564 Participants
Region of Enrollment
United States
212 participants198 participants209 participants619 participants
Sex: Female, Male
Female
97 Participants105 Participants100 Participants302 Participants
Sex: Female, Male
Male
115 Participants93 Participants109 Participants317 Participants
Smoking Status
Current Smoker
102 Participants96 Participants103 Participants301 Participants
Smoking Status
Former Smoker
110 Participants102 Participants106 Participants318 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 2120 / 1981 / 209
other
Total, other adverse events
51 / 21246 / 19851 / 209
serious
Total, serious adverse events
10 / 21210 / 19814 / 209

Outcome results

Primary

Change From Baseline in Trough FEV1 on Day 85

Time frame: Day 85

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

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
TD-4208-1Change From Baseline in Trough FEV1 on Day 8559.81 mLStandard Error 15.095
TD-4208-2Change From Baseline in Trough FEV1 on Day 85126.85 mLStandard Error 15.389
PlaceboChange From Baseline in Trough FEV1 on Day 85-19.41 mLStandard Error 16.108
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 Periods48.35 Percentage of 24 hr periodsStandard Error 2.784
TD-4208-2Percentage of Albuterol Rescue-free 24-hour Periods43.57 Percentage of 24 hr periodsStandard Error 2.829
PlaceboPercentage of Albuterol Rescue-free 24-hour Periods45.21 Percentage of 24 hr periodsStandard Error 2.89
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: Baseline to Day 85

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TD-4208-1St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 8570 Participants
TD-4208-2St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 8568 Participants
PlaceboSt. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 8546 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 Dose218.14 mLStandard Error 9.546
TD-4208-2Summary of Change From Baseline to Peak FEV1 After First Dose224.46 mLStandard Error 9.744
PlaceboSummary of Change From Baseline to Peak FEV1 After First Dose91.79 mLStandard Error 9.963
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 Day2.26 Puffs per DayStandard Error 0.234
TD-4208-2Summary of Rescue Medication Use: Puffs Per Day2.27 Puffs per DayStandard Error 0.239
PlaceboSummary of Rescue Medication Use: Puffs Per Day2.72 Puffs per DayStandard Error 0.246
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 8573.0 mLStandard Error 3.1
TD-4208-2Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85124.8 mLStandard Error 3.2
PlaceboSummary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85-30.8 mLStandard Error 3.18

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