Trial Outcomes & Findings for Safety & Efficacy of BCT197A2201 in COPD Patients Presenting With an Exacerbation (NCT NCT01332097)
NCT ID: NCT01332097
Last Updated: 2023-03-21
Results Overview
Change in FEV1 from baseline to Day 5 or baseline to Day 10 measured in mL Measure: FEV1 Change in Forced Expiry Volume in 1 second
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
183 participants
Primary outcome timeframe
Day 5, Day 10
Results posted on
2023-03-21
Participant Flow
Participant milestones
| Measure |
Treatment A
Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules
BCT197
Prednisone placebo: capsules
|
Treatment C
Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules
Prednisone placebo: capsules
BCT197 placebo: capsules
|
Treatment D
Single oral dose of 20mg dose of BCT197 capsules
BCT197
|
Treatment F
Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6
BCT197
|
Treatment H
Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6
BCT197
|
Treatment B,E,G I
Matching placebo group Treatment B - Single oral dose of BCT placebo Treatment E - Single oral dose of BCT197 placebo and prednisone placebo Treatment G - Single oral dose of BCT197 placebo and Treatment I - Single oral dose of BCT197 placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
25
|
27
|
25
|
45
|
|
Overall Study
COMPLETED
|
30
|
26
|
23
|
24
|
22
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
2
|
3
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety & Efficacy of BCT197A2201 in COPD Patients Presenting With an Exacerbation
Baseline characteristics by cohort
| Measure |
Treatment A
n=31 Participants
Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules
BCT197
Prednisone placebo: capsules
|
Treatment B, E,G & I
n=45 Participants
Matched placebo arms
BCT197 placebo: capsules
Prednisone placebo: capsules
|
Treatment C
n=30 Participants
Single oral dose of BCT197 placebo capsules + single oral dose of 40mg prednisone capsules
Prednisone: capsules
BCT197 placebo: capsules
|
Treatment D
n=25 Participants
Single oral dose of 20mg dose of BCT197 capsules
BCT197
|
Treatment F
n=27 Participants
Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6
BCT197
|
Treatment H
n=25 Participants
Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6
BCT197
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
61 Years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
63 Years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
62 Years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
61 Years
STANDARD_DEVIATION 9.1 • n=21 Participants
|
64 Years
STANDARD_DEVIATION 6.7 • n=10 Participants
|
62 Years
STANDARD_DEVIATION 7.9 • n=115 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
37 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
146 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
183 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 5, Day 10Population: The PD analysis set included all participants without major protocol deviations that impacted efficacy/pharmacodynamic data. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and "Number analyzed" is the number of participants evaluated at each time point.
Change in FEV1 from baseline to Day 5 or baseline to Day 10 measured in mL Measure: FEV1 Change in Forced Expiry Volume in 1 second
Outcome measures
| Measure |
Treatment A
n=30 Participants
Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules
BCT197
Prednisone placebo: capsules
|
Treatment B, E, G & I
n=45 Participants
Matched Placebo arms
BCT197 placebo: capsules
Prednisone placebo: capsules
|
Treatment C
n=30 Participants
Single oral dose of BCT197 placebo capsules + single oral dose of 40mg prednisone capsules
Prednisone
BCT197 placebo: capsules
|
Treatment D
n=25 Participants
Single oral dose of 20mg dose of BCT197 capsules
BCT197
|
Treatment F
n=26 Participants
Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6
BCT197
|
Treatment H
n=25 Participants
Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6
BCT197
|
|---|---|---|---|---|---|---|
|
Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second
Day 5
|
155.1 mL
Interval 80.8 to 229.3
|
100.8 mL
Interval 40.0 to 161.7
|
48.9 mL
Interval -25.6 to 123.3
|
106.3 mL
Interval 24.7 to 187.9
|
134.4 mL
Interval 54.6 to 214.1
|
200.6 mL
Interval 119.0 to 282.3
|
|
Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second
Day 10
|
164.6 mL
Interval 51.0 to 278.3
|
126.9 mL
Interval 37.0 to 216.8
|
54.9 mL
Interval -56.8 to 166.7
|
54.6 mL
Interval -88.8 to 198.0
|
109.0 mL
Interval 5.6 to 212.5
|
250.5 mL
Interval 144.5 to 356.4
|
SECONDARY outcome
Timeframe: Up to Day 29Population: The PD analysis set included all participants without major protocol deviations that impacted efficacy/pharmacodynamic data. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
EXAcerbations of Chronic pulmonary disease tool patient reported outcome (EXACT-PRO) Rolling Average Improvement from Day 1 to Day 29. EXACT-PRO is a 14 point patient reported daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD). Minimum score is 0 and Maximum score is 14 (higher scores indicate worsening indicative of an exacerbation). Reported value is LS mean improvement from at Day 29 compared to D1 of the study.
Outcome measures
| Measure |
Treatment A
n=25 Participants
Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules
BCT197
Prednisone placebo: capsules
|
Treatment B, E, G & I
n=41 Participants
Matched Placebo arms
BCT197 placebo: capsules
Prednisone placebo: capsules
|
Treatment C
n=26 Participants
Single oral dose of BCT197 placebo capsules + single oral dose of 40mg prednisone capsules
Prednisone
BCT197 placebo: capsules
|
Treatment D
n=23 Participants
Single oral dose of 20mg dose of BCT197 capsules
BCT197
|
Treatment F
n=24 Participants
Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6
BCT197
|
Treatment H
n=24 Participants
Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6
BCT197
|
|---|---|---|---|---|---|---|
|
Rolling Average Improvement From Day 1 to Day 29 Using the EXACT-PRO 14 Point Patient Reported Outcome Measure: EXACT-PRO
|
5.72 score on a scale
Interval 0.55 to 10.9
|
8.89 score on a scale
Interval 4.74 to 13.05
|
5.19 score on a scale
Interval 0.02 to 10.36
|
5.83 score on a scale
Interval -0.35 to 12.01
|
7.89 score on a scale
Interval 2.58 to 13.2
|
8.35 score on a scale
Interval 2.59 to 14.11
|
Adverse Events
Treatment A
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Treatment B, E, G & I
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Treatment C
Serious events: 5 serious events
Other events: 16 other events
Deaths: 2 deaths
Treatment D
Serious events: 2 serious events
Other events: 13 other events
Deaths: 1 deaths
Treatment F
Serious events: 3 serious events
Other events: 14 other events
Deaths: 1 deaths
Treatment H
Serious events: 3 serious events
Other events: 16 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment A
n=31 participants at risk
Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules
BCT197
Prednisone placebo: capsules
|
Treatment B, E, G & I
n=45 participants at risk
Matching placebo
Single oral dose of BCT197 placebo capsules + single oral dose of prednisone placebo capsules
Prednisone placebo: capsules
BCT197 placebo: capsules
|
Treatment C
n=30 participants at risk
Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules
Prednisone placebo: capsules
BCT197 placebo: capsules
|
Treatment D
n=25 participants at risk
Single oral dose of 20mg dose of BCT197 capsules
BCT197
|
Treatment F
n=27 participants at risk
Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6
BCT197
|
Treatment H
n=25 participants at risk
Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6
BCT197
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/31 • 6 months
|
2.2%
1/45 • Number of events 1 • 6 months
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
3.7%
1/27 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
6.5%
2/31 • Number of events 3 • 6 months
|
6.7%
3/45 • Number of events 3 • 6 months
|
10.0%
3/30 • Number of events 4 • 6 months
|
4.0%
1/25 • Number of events 1 • 6 months
|
7.4%
2/27 • Number of events 3 • 6 months
|
12.0%
3/25 • Number of events 4 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/31 • 6 months
|
0.00%
0/45 • 6 months
|
0.00%
0/30 • 6 months
|
4.0%
1/25 • Number of events 1 • 6 months
|
0.00%
0/27 • 6 months
|
0.00%
0/25 • 6 months
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/45 • 6 months
|
0.00%
0/30 • 6 months
|
0.00%
0/25 • 6 months
|
0.00%
0/27 • 6 months
|
0.00%
0/25 • 6 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/31 • 6 months
|
0.00%
0/45 • 6 months
|
0.00%
0/30 • 6 months
|
0.00%
0/25 • 6 months
|
3.7%
1/27 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
|
Cardiac disorders
Cardiac Failure Acute
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/45 • 6 months
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
0.00%
0/27 • 6 months
|
0.00%
0/25 • 6 months
|
|
Nervous system disorders
Cerebral Edema
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/45 • 6 months
|
0.00%
0/30 • 6 months
|
0.00%
0/25 • 6 months
|
0.00%
0/27 • 6 months
|
0.00%
0/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Decompensated Chronic Respiratory Failure
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/45 • 6 months
|
0.00%
0/30 • 6 months
|
0.00%
0/25 • 6 months
|
0.00%
0/27 • 6 months
|
0.00%
0/25 • 6 months
|
|
Cardiac disorders
Attrial Flutter
|
0.00%
0/31 • 6 months
|
0.00%
0/45 • 6 months
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
0.00%
0/27 • 6 months
|
0.00%
0/25 • 6 months
|
|
General disorders
Sudden cardiac death
|
0.00%
0/31 • 6 months
|
0.00%
0/45 • 6 months
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
0.00%
0/27 • 6 months
|
0.00%
0/25 • 6 months
|
|
Nervous system disorders
Stoke
|
0.00%
0/31 • 6 months
|
0.00%
0/45 • 6 months
|
0.00%
0/30 • 6 months
|
0.00%
0/25 • 6 months
|
3.7%
1/27 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
Other adverse events
| Measure |
Treatment A
n=31 participants at risk
Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules
BCT197
Prednisone placebo: capsules
|
Treatment B, E, G & I
n=45 participants at risk
Matching placebo
Single oral dose of BCT197 placebo capsules + single oral dose of prednisone placebo capsules
Prednisone placebo: capsules
BCT197 placebo: capsules
|
Treatment C
n=30 participants at risk
Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules
Prednisone placebo: capsules
BCT197 placebo: capsules
|
Treatment D
n=25 participants at risk
Single oral dose of 20mg dose of BCT197 capsules
BCT197
|
Treatment F
n=27 participants at risk
Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6
BCT197
|
Treatment H
n=25 participants at risk
Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6
BCT197
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/31 • 6 months
|
0.00%
0/45 • 6 months
|
0.00%
0/30 • 6 months
|
0.00%
0/25 • 6 months
|
0.00%
0/27 • 6 months
|
8.0%
2/25 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/31 • 6 months
|
0.00%
0/45 • 6 months
|
0.00%
0/30 • 6 months
|
0.00%
0/25 • 6 months
|
0.00%
0/27 • 6 months
|
8.0%
2/25 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/31 • 6 months
|
0.00%
0/45 • 6 months
|
6.7%
2/30 • Number of events 2 • 6 months
|
0.00%
0/25 • 6 months
|
0.00%
0/27 • 6 months
|
8.0%
2/25 • Number of events 2 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
2/31 • Number of events 2 • 6 months
|
4.4%
2/45 • Number of events 2 • 6 months
|
10.0%
3/30 • Number of events 3 • 6 months
|
16.0%
4/25 • Number of events 4 • 6 months
|
14.8%
4/27 • Number of events 4 • 6 months
|
4.0%
1/25 • Number of events 1 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/31 • 6 months
|
0.00%
0/45 • 6 months
|
0.00%
0/30 • 6 months
|
0.00%
0/25 • 6 months
|
0.00%
0/27 • 6 months
|
8.0%
2/25 • Number of events 2 • 6 months
|
|
Investigations
Occult blood
|
9.7%
3/31 • Number of events 3 • 6 months
|
6.7%
3/45 • Number of events 3 • 6 months
|
10.0%
3/30 • Number of events 3 • 6 months
|
20.0%
5/25 • Number of events 5 • 6 months
|
14.8%
4/27 • Number of events 4 • 6 months
|
0.00%
0/25 • 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/31 • 6 months
|
6.7%
3/45 • Number of events 3 • 6 months
|
10.0%
3/30 • Number of events 3 • 6 months
|
4.0%
1/25 • Number of events 1 • 6 months
|
3.7%
1/27 • Number of events 1 • 6 months
|
0.00%
0/25 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/31 • 6 months
|
26.7%
12/45 • Number of events 12 • 6 months
|
16.7%
5/30 • Number of events 5 • 6 months
|
16.0%
4/25 • Number of events 4 • 6 months
|
18.5%
5/27 • Number of events 5 • 6 months
|
24.0%
6/25 • Number of events 6 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/31 • 6 months
|
0.00%
0/45 • 6 months
|
0.00%
0/30 • 6 months
|
0.00%
0/25 • 6 months
|
0.00%
0/27 • 6 months
|
8.0%
2/25 • Number of events 2 • 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/31 • 6 months
|
0.00%
0/45 • 6 months
|
6.7%
2/30 • Number of events 2 • 6 months
|
0.00%
0/25 • 6 months
|
0.00%
0/27 • 6 months
|
0.00%
0/25 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All PIs must seek written permission from the sponsor before publication of any trial results.
- Publication restrictions are in place
Restriction type: OTHER