Quantifying Airway Inflammation With Radiologic Tests

This study has been completed.
Sponsor:
Collaborator:
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00741013
First received: August 21, 2008
Last updated: April 22, 2014
Last verified: April 2014
Results First Received: August 4, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Lung Inflammation
Interventions: Drug: placebo pill and placebo IV
Drug: Lovastatin pill and placebo IV
Drug: placebo pill and recombinant human activated protein C IV
Biological: Endotoxin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Placebo Pill and Intravenous (i.v.) Placebo     Lovastatin Pill and i.v. Placebo     Placebo Pill and Recombinant Human Activated Protein C i.v.  
STARTED     7     8     7  
COMPLETED     6     6     6  
NOT COMPLETED     1     2     1  
Adverse Event                 1                 0                 0  
Withdrawal by Subject                 0                 0                 1  
Discovered failed screen after enrolled                 0                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Placebo Pill and Intravenous (i.v.) Placebo     Lovastatin Pill and i.v. Placebo     Placebo Pill and Recombinant Human Activated Protein C i.v.     Total  
Number of Participants  
[units: participants]
  7     8     7     22  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     7     8     7     22  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     2     2     1     5  
Male     5     6     6     17  
Region of Enrollment  
[units: participants]
       
United States     7     8     7     22  



  Outcome Measures
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1.  Primary:   Change in Ki (Measure of [18F]Fluorodeoxyglucose ([18F]FDG) Uptake Determined by Patlak Graphical Analysis) in the Right Lung 24 Hours After LPS Instillation   [ Time Frame: 24 hours after endotoxin instillation ]

2.  Secondary:   Number of Total Nucleated Cells From Bronchoalveolar Lavage (BAL) Fluid 24 Hours After Endotoxin Instillation   [ Time Frame: 24 hours after endotoxin instillation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Delphine L. Chen
Organization: Washington University School of Medicine
phone: 314-362-7029
e-mail: chend@mir.wustl.edu


Publications of Results:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00741013     History of Changes
Other Study ID Numbers: 05-1137
Study First Received: August 21, 2008
Results First Received: August 4, 2009
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration