Trial Outcomes & Findings for A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02040792)
NCT ID: NCT02040792
Last Updated: 2022-02-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
355 participants
Primary outcome timeframe
Baseline to 28 days
Results posted on
2022-02-24
Participant Flow
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK (GlaxoSmithKline) study with another investigational agent at the same time as their participation in this study.
Participant milestones
| Measure |
Placebo
Placebo
Placebo
|
44 mcg
TD-4208
TD-4208
|
88 mcg
TD-4208
TD-4208
|
175 mcg
TD-4208
TD-4208
|
350 mcg
TD-4208
TD-4208
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
70
|
68
|
71
|
71
|
74
|
|
Overall Study
COMPLETED
|
64
|
65
|
68
|
64
|
67
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
3
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Placebo
n=70 Participants
Placebo
Placebo
|
44 mcg
n=68 Participants
TD-4208
TD-4208
|
88 mcg
n=71 Participants
TD-4208
TD-4208
|
175 mcg
n=71 Participants
TD-4208
TD-4208
|
350 mcg
n=74 Participants
TD-4208
TD-4208
|
Total
n=354 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 9.17 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 8.87 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 7.98 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 7.69 • n=4 Participants
|
61.4 years
STANDARD_DEVIATION 8.98 • n=21 Participants
|
61.9 years
STANDARD_DEVIATION 8.63 • n=8 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
176 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
178 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline to 28 daysOutcome measures
| Measure |
Placebo
n=70 Participants
Placebo
Placebo
|
44 mcg
n=68 Participants
TD-4208
TD-4208
|
88 mcg
n=71 Participants
TD-4208
TD-4208
|
175 mcg
n=71 Participants
TD-4208
TD-4208
|
350 mcg
n=74 Participants
TD-4208
TD-4208
|
|---|---|---|---|---|---|
|
Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)
|
-32.4 mL
Standard Error 25.36
|
19.4 mL
Standard Error 24.98
|
155.0 mL
Standard Error 24.61
|
134.2 mL
Standard Error 25.07
|
138.2 mL
Standard Error 24.38
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
44 mcg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
88 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
175 mcg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
350 mcg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=71 participants at risk
Placebo
Placebo
|
44 mcg
n=68 participants at risk
TD-4208
TD-4208
|
88 mcg
n=71 participants at risk
TD-4208
TD-4208
|
175 mcg
n=71 participants at risk
TD-4208
TD-4208
|
350 mcg
n=74 participants at risk
TD-4208
TD-4208
|
|---|---|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
1.5%
1/68 • Number of events 1
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/74
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/68
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
1.4%
1/71 • Number of events 1
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/74
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/68
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
1.4%
1/71 • Number of events 1
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/74
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/68
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
1.4%
1/74 • Number of events 1
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
Other adverse events
| Measure |
Placebo
n=71 participants at risk
Placebo
Placebo
|
44 mcg
n=68 participants at risk
TD-4208
TD-4208
|
88 mcg
n=71 participants at risk
TD-4208
TD-4208
|
175 mcg
n=71 participants at risk
TD-4208
TD-4208
|
350 mcg
n=74 participants at risk
TD-4208
TD-4208
|
|---|---|---|---|---|---|
|
General disorders
Headache
|
2.8%
2/71 • Number of events 2
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
1.5%
1/68 • Number of events 1
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
2.8%
2/71 • Number of events 2
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
1.4%
1/71 • Number of events 1
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
6.8%
5/74 • Number of events 5
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.8%
2/71 • Number of events 2
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/68
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
4.2%
3/71 • Number of events 3
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
4.2%
3/71 • Number of events 3
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
2.7%
2/74 • Number of events 2
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/71 • Number of events 1
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/68
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
4.2%
3/71 • Number of events 3
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
4.1%
3/74 • Number of events 3
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
2.8%
2/71 • Number of events 2
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/68
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
1.4%
1/71 • Number of events 1
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
2.7%
2/74 • Number of events 2
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/68
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
1.4%
1/71 • Number of events 1
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
2.8%
2/71 • Number of events 2
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
1.4%
1/74 • Number of events 1
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
|
General disorders
Oropharyngeal pain
|
1.4%
1/71 • Number of events 1
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
1.5%
1/68 • Number of events 1
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
0.00%
0/71
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
2.7%
2/74 • Number of events 2
One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.
|
Additional Information
Head of Clinical Development & Medical Affairs
Theravance Biopharma
Phone: 1-855-633-8479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may communicate the trial results generated by the PI, but only after the first publication or presentation of the combined study results generated by all participating sites. The Sponsor can then review trial results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The Sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER