Trial Outcomes & Findings for A Study Designed to Evaluate ODSH in Subjects With Exacerbations of COPD (NCT NCT00457951)
NCT ID: NCT00457951
Last Updated: 2021-12-02
Results Overview
The primary outcome of the study is "Treatment Failure" as defined by Failure to discharge from hospital based on GOLD (Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) criteria or relapse after DC from hospital.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
158 participants
Primary outcome timeframe
Time to hospital discharge and 21 days post-treatment, up to 31 days
Results posted on
2021-12-02
Participant Flow
Participant milestones
| Measure |
Open Label
Open Label
The original protocol called for 304 subjects with exacerbation of COPD to be enrolled into the study. Thirteen patients with exacerbation of COPD were enrolled in the initial open label portion of the study. Of these thirteen subjects, the initial seven subjects were treated with an IV bolus of ODSH at 8 mg/kg followed by a continuous infusion of ODSH at 0.5 mg/kg/hr for 72 hours.
After an ad hoc safety committee assessed the safety of the data from the first seven subjects, six more subjects were treated concomitantly treated with ODSH and enoxaparin, a low molecular weight heparin commonly used for seriously ill hospitalized patients as DVT prophylaxis.
|
Placebo Comparator: 0.9% Sodium Chloride
Double-blind randomized phase: Normal Saline infusion: Bolus infusion followed by a 4 day continuous infusion of placebo.
|
ODSH Treatment Group
Double-blind randomized phase: The subjects receiving ODSH in the randomized portion of the study received 0.375 mg/kg/hr continuous IV infusion of ODSH for 96 hours.
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|---|---|---|---|
|
Overall Study
STARTED
|
13
|
66
|
72
|
|
Overall Study
COMPLETED
|
13
|
50
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
16
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Designed to Evaluate ODSH in Subjects With Exacerbations of COPD
Baseline characteristics by cohort
| Measure |
Open-Label
n=13 Participants
Open-Label ODSH
|
Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride
n=66 Participants
Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD
|
ODSH Treatment Group
n=72 Participants
ODSH Treatment Group Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
63.8 years
STANDARD_DEVIATION 15 • n=5 Participants
|
68.5 years
STANDARD_DEVIATION 10.24 • n=7 Participants
|
67.2 years
STANDARD_DEVIATION 9.53 • n=5 Participants
|
66.5 years
STANDARD_DEVIATION 10.43 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
9 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
4 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
66 participants
n=7 Participants
|
72 participants
n=5 Participants
|
151 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Time to hospital discharge and 21 days post-treatment, up to 31 daysPopulation: Of the 138 subjects randomized, 132 were analyzed in the intent-to-treat population. Of the 6 excluded from the intent-to-treat population, 4 did not receive study drug and 2 lacked information for assessment.
The primary outcome of the study is "Treatment Failure" as defined by Failure to discharge from hospital based on GOLD (Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease) criteria or relapse after DC from hospital.
Outcome measures
| Measure |
0.9% Sodium Chloride
n=64 Participants
Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.
Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride
|
Randomized, Blinded, ODSH Arm
n=68 Participants
Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.
ODSH: Randomized, Blinded, ODSH Arm
|
|---|---|---|
|
Incidence of Treatment Failure
|
24.6 percentage of failures
Interval 14.0 to 43.0
|
32.4 percentage of failures
Interval 21.0 to 42.0
|
Adverse Events
Open Label
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Comparator: 0.9% Sodium Chloride
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
ODSH Treatment Group
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Label
n=13 participants at risk
Initial six subjects treated with ODSH open-label to confirm safety in subjects with an acute exacerbation of COPD; six additional patients will be enrolled following safety review.
Open-Label: ODSH administered open-label
|
Placebo Comparator: 0.9% Sodium Chloride
n=65 participants at risk
Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.
Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride
|
ODSH Treatment Group
n=69 participants at risk
Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.
ODSH: Randomized, Blinded, ODSH Arm
|
|---|---|---|---|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/13 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
0.00%
0/65 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
1.4%
1/69 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/13 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
0.00%
0/65 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
1.4%
1/69 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.00%
0/13 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
1.5%
1/65 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
0.00%
0/69 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/13 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
1.5%
1/65 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
0.00%
0/69 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/13 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
1.5%
1/65 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
0.00%
0/69 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/13 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
1.5%
1/65 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
0.00%
0/69 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/13 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
1.5%
1/65 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
0.00%
0/69 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.7%
1/13 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
0.00%
0/65 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
0.00%
0/69 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
Other adverse events
| Measure |
Open Label
n=13 participants at risk
Initial six subjects treated with ODSH open-label to confirm safety in subjects with an acute exacerbation of COPD; six additional patients will be enrolled following safety review.
Open-Label: ODSH administered open-label
|
Placebo Comparator: 0.9% Sodium Chloride
n=65 participants at risk
Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.
Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride
|
ODSH Treatment Group
n=69 participants at risk
Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.
ODSH: Randomized, Blinded, ODSH Arm
|
|---|---|---|---|
|
Hepatobiliary disorders
ALT Increased
|
0.00%
0/13 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
10.8%
7/65 • Number of events 8 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
37.7%
26/69 • Number of events 33 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
|
Hepatobiliary disorders
AST Increased
|
0.00%
0/13 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
9.2%
6/65 • Number of events 6 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
31.9%
22/69 • Number of events 29 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
4.6%
3/65 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
5.8%
4/69 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
1.5%
1/65 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
5.8%
4/69 • D1 to D90
Of the 145 subjects consented in the randomized phase, 138 were randomized. Of the 138 randomized subjects, 134 were included in the safety population; 4 of the 138 randomized subjects did not receive study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Confidentiality and Non-Disclosure Agreement
- Publication restrictions are in place
Restriction type: OTHER