Effect of High Levels of Oxygen and Smoking on the Lungs in Human Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001464
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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.

Condition or disease Intervention/treatment Phase
Healthy Hyperoxia Procedure: Oxygen therapy Phase 1

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 (e.g., 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Primary Purpose: Treatment
Official Title: Effect of Hypoxia and Smoking on Oxidation of Proteins and Nucleic Acids in Human Volunteers
Study Start Date : August 1, 1995
Actual Primary Completion Date : July 10, 2007
Actual Study Completion Date : July 10, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

History - good overall health without history of recent (within 3 months) acute disease;

Physical examination within normal limits;

Laboratory evaluation; including complete blood count (CBC), serum electrolyte determinations, clotting times, chest x-ray, pulmonary function testing, and an electrocardiogram (EKG) - within normal limits;

Non-smokers defined as having never smoked or not smoked in the past 2 years;

Smokers defined as moderate (1 pack per day for 3+ years) or heavy (1-2 packs for 10+ years);

Subjects must be willing to make the time commitment necessary for the study.


Any study subject who does not fulfill the criteria for eligibility.

Individuals with a history of allergy or adverse reactions to atropine or any local anesthetic;

Individuals testing positive for the human immunodeficiency virus or hepatitis virus;

Individuals on chronic medications or currently receiving medications;

Pregnant or lactating individuals, since the effects of hyperoxia on the fetus are unclear.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001464

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Joel Moss, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI) Identifier: NCT00001464     History of Changes
Other Study ID Numbers: 950167
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: October 24, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Bronchoalveolar Lavage
DNA Repair
Carbonyl Groups
Protein Oxidation
Human Volunteers

Additional relevant MeSH terms:
Signs and Symptoms, Respiratory
Signs and Symptoms