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NCT00094406 · ClinicalTrials.gov registry record · Phase 1
Carbon Monoxide to Prevent Lung Inflammation
A Phase 1 study of Respiratory Distress Syndrome, Adult, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT00094406: Completed Phase 1 study of Respiratory Distress Syndrome, Adult, sponsored by National Institutes of Health Clinical Center (CC).
NCT00094406 is a Phase 1 study of Respiratory Distress Syndrome, Adult that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 35 participants, below the 321-participant average among 7 other Respiratory Distress Syndrome, Adult trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00094406, a Phase 1 study of Respiratory Distress Syndrome, Adult, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine in healthy volunteers how breathing carbon monoxide (CO) affects lung inflammation. Severe lung inflammation sometimes develops in patients with pneumonia or patients who develop serious blood stream infections. Studies in the laboratory and in animals show that CO can decrease lung inflammation. Healthy volunteers between 18 and 40 years of age who do not smoke, are not taking any medications, do not have asthma, are not allergic to sulfa- and penicillin-based drugs, and are not pregnant may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), and chest x-ray. Subjects are enrolled in either a pilot study or the main study. Participants undergo bronchoscopy and bronchoalveolar lavage to study the effects of endotoxin (a component of bacteria that causes inflammation similar to that in patients with lung infections) on lung function. Before the procedure, a small plastic tube (catheter) is placed in a vein to collect blood samples and another is placed in an artery to check blood pressure. For the bronchoscopy, the mouth and nasal airways are numbed with lidocaine, and a bronchoscope (thin flexible tube) is passed through the nose into the airways of the lung. A small amount of salt water is squirted through the bronchoscope into one lung and then salt water containing endotoxin is squirted into the other lung. Following the bronchoscopy, subjects are treated with either CO or room air (placebo) for 6 hours. (Subjects in the pilot study receive treatment for only 3 hours). The gas is delivered through a cushioned mask placed over the nose and mouth. The amount of exhaled CO is measured before, during, and after inhalation of the gas. For this measurement, subjects take a deep breath to fill up their lungs and slowly exhale into a mouthpiece connected to a measuring device until they feel their lungs are empty. After the CO treatment, a second b
Conditions Studied
Interventions
- PROCEDURE Bronchoscopy
- DRUG Endotoxin
- PROCEDURE Bronchoalveolar lavage
- DRUG Carbon Monoxide
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2004-10-13 |
| Est. Completion | 2010-03-11 |
| Phase | Phase 1 |
What the finished NCT00094406 record still lists
NCT00094406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 321-participant average among 7 other Respiratory Distress Syndrome, Adult trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Respiratory Distress Syndrome, Adult appearing as the primary indexed condition, and to 4 interventions - of which Bronchoscopy is the first listed.
NCT00094406 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00094406 about?
NCT00094406 is a clinical study titled "Carbon Monoxide to Prevent Lung Inflammation". This study will examine in healthy volunteers how breathing carbon monoxide (CO) affects lung inflammation. Severe lung inflammation sometimes develops in patients with pneumonia or patients who develop serious blood stream infections. Studies in the laboratory and in animals show that CO can decrea...
What is the current status of trial NCT00094406?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2004-10-13. Estimated completion is 2010-03-11.
What conditions does trial NCT00094406 study?
This clinical trial studies the following conditions: Respiratory Distress Syndrome, Adult.
What interventions are being tested in trial NCT00094406?
The interventions under investigation include: Bronchoscopy (PROCEDURE), Endotoxin (DRUG), Bronchoalveolar lavage (PROCEDURE), Carbon Monoxide (DRUG).
Who is sponsoring clinical trial NCT00094406?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00094406 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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