Viewing Study NCT00001464



Ignite Creation Date: 2024-05-05 @ 11:21 AM
Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001464
Status: COMPLETED
Last Update Posted: 2021-08-27
First Post: 1999-11-03

Brief Title: Effect of High Levels of Oxygen and Smoking on the Lungs in Human Volunteers
Sponsor: National Heart Lung and Blood Institute NHLBI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Effect of Hypoxia and Smoking on Oxidation of Proteins and Nucleic Acids in Human Volunteers
Status: COMPLETED
Status Verified Date: 2021-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Patients with lung disease experiencing difficulty breathing can be treated with oxygen therapy This involves the delivery of extra oxygen by a face-mask or through small tubes placed in the nose called nasal prongs This extra oxygen can have concentrations as high as 100 pure oxygen The concentration of oxygen in normal air is only 21 The high concentration of oxygen can help to provide enough oxygen for all of the organs in the body Unfortunately breathing 100 oxygen for long periods of time can cause changes in the lungs which are potentially harmful Researchers believe that by lowering the concentration of oxygen therapy to 40 patients can receive it for longer periods of time without the risk of side effects

This study is designed to evaluate the effects of oxygen therapy at 100 and 40 for 12 18 hours on the lungs of normal volunteers Results of this study will help to determine if levels of oxygen therapy currently accepted as being safe may actually be damaging to the lungs
Detailed Description: Stress such as high oxygen or inflammation can result in damage to proteins by processes such as oxidation or alternative regulation of signaling pathways by post-translational modification of proteins eg phosphorylation Delivery of oxygen in high concentrations to the lungs can result in damage which is mediated in large part by reactive oxygen species Inflammation can result in activation of intracellular signaling pathways This study will evaluate modification of proteins and nucleic acids in bronchoalveolar lavage fluid bronchial epithelial cells and peripheral blood of individuals exposed to oxygen or who are smokers In doing so it will determine the effects of hyperoxia or inflammation on the lung

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
95-H-0167 None None None