Trial Outcomes & Findings for Quantifying Airway Inflammation With Radiologic Tests (NCT NCT00741013)
NCT ID: NCT00741013
Last Updated: 2014-05-26
Results Overview
Calculated Ki was used to measure the amount of lung inflammation before and after instillation of endotoxin to assess the effect of placebo, lovastatin, and rhAPC treatment
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
22 participants
Primary outcome timeframe
24 hours after endotoxin instillation
Results posted on
2014-05-26
Participant Flow
Participant milestones
| Measure |
Placebo Pill and Intravenous (i.v.) Placebo
Control group receiving only placebo drug interventions
|
Lovastatin Pill and i.v. Placebo
Group receiving lovastatin as the primary drug intervention
|
Placebo Pill and Recombinant Human Activated Protein C i.v.
Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
7
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Placebo Pill and Intravenous (i.v.) Placebo
Control group receiving only placebo drug interventions
|
Lovastatin Pill and i.v. Placebo
Group receiving lovastatin as the primary drug intervention
|
Placebo Pill and Recombinant Human Activated Protein C i.v.
Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Discovered failed screen after enrolled
|
0
|
2
|
0
|
Baseline Characteristics
Quantifying Airway Inflammation With Radiologic Tests
Baseline characteristics by cohort
| Measure |
Placebo Pill and Intravenous (i.v.) Placebo
n=7 Participants
Control group receiving only placebo drug interventions
|
Lovastatin Pill and i.v. Placebo
n=8 Participants
Group receiving lovastatin as the primary drug intervention
|
Placebo Pill and Recombinant Human Activated Protein C i.v.
n=7 Participants
Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
7 participants
n=206 Participants
|
22 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 24 hours after endotoxin instillationCalculated Ki was used to measure the amount of lung inflammation before and after instillation of endotoxin to assess the effect of placebo, lovastatin, and rhAPC treatment
Outcome measures
| Measure |
Placebo Pill and Intravenous (i.v.) Placebo
n=6 Participants
Control group receiving only placebo drug interventions
|
Lovastatin Pill and i.v. Placebo
n=6 Participants
Group receiving lovastatin as the primary drug intervention
|
Placebo Pill and Recombinant Human Activated Protein C i.v.
n=6 Participants
Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
|
|---|---|---|---|
|
Change in Ki (Measure of [18F]Fluorodeoxyglucose ([18F]FDG) Uptake Determined by Patlak Graphical Analysis) in the Right Lung 24 Hours After LPS Instillation
|
18.8 Change in Ki
Standard Deviation 9.2
|
8.4 Change in Ki
Standard Deviation 4.3
|
14.2 Change in Ki
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 24 hours after endotoxin instillationNumber of total nucleated cells isolated from the first aliquoe of BAL obtained to correlate with PET data.
Outcome measures
| Measure |
Placebo Pill and Intravenous (i.v.) Placebo
n=6 Participants
Control group receiving only placebo drug interventions
|
Lovastatin Pill and i.v. Placebo
n=6 Participants
Group receiving lovastatin as the primary drug intervention
|
Placebo Pill and Recombinant Human Activated Protein C i.v.
n=6 Participants
Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
|
|---|---|---|---|
|
Number of Total Nucleated Cells From Bronchoalveolar Lavage (BAL) Fluid 24 Hours After Endotoxin Instillation
|
545 cells per cubic mm
Standard Deviation 425
|
311 cells per cubic mm
Standard Deviation 237
|
520 cells per cubic mm
Standard Deviation 196
|
Adverse Events
Placebo Pill and Intravenous (i.v.) Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Lovastatin Pill and i.v. Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Pill and Recombinant Human Activated Protein C i.v.
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Pill and Intravenous (i.v.) Placebo
n=7 participants at risk
Control group receiving only placebo drug interventions
|
Lovastatin Pill and i.v. Placebo
n=8 participants at risk
Group receiving lovastatin as the primary drug intervention
|
Placebo Pill and Recombinant Human Activated Protein C i.v.
n=7 participants at risk
Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Decreased pulmonary function
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/7
|
Other adverse events
| Measure |
Placebo Pill and Intravenous (i.v.) Placebo
n=7 participants at risk
Control group receiving only placebo drug interventions
|
Lovastatin Pill and i.v. Placebo
n=8 participants at risk
Group receiving lovastatin as the primary drug intervention
|
Placebo Pill and Recombinant Human Activated Protein C i.v.
n=7 participants at risk
Group receiving recombinant human activated protein C (rhAPC) as the drug intervention
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
42.9%
3/7 • Number of events 3
|
|
General disorders
Fever
|
42.9%
3/7 • Number of events 4
|
25.0%
2/8 • Number of events 2
|
28.6%
2/7 • Number of events 2
|
|
General disorders
Headache
|
28.6%
2/7 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
42.9%
3/7 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
28.6%
2/7 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
28.6%
2/7 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
28.6%
2/7 • Number of events 2
|
0.00%
0/8
|
14.3%
1/7 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
|
Skin and subcutaneous tissue disorders
Rash under neck
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
|
General disorders
Body ache
|
14.3%
1/7 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
|
General disorders
General body discomfort
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/7
|
Additional Information
Delphine L. Chen
Washington University School of Medicine
Phone: 314-362-7029
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place