Protocol Number: 95-H-0167

Title:

Effect of Hypoxia and Smoking on Oxidation of Proteins and Nucleic Acids in Human Volunteers

Number:

95-H-0167

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.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Special Instructions:

This protocol includes 3 bronchoscopies. I t includes 3 visits 2 weeks apart. The 2nd visit involves oxygen by mask for 14-18 hours.

Keywords:

Oxygen

Bronchoalveolar Lavage

DNA Repair

Carbonyl Groups

Serum

Alpha1-antitrypsin

ADP-ribosylation

Defensin

Protein Oxidation

Recruitment Keywords:

Human Volunteers

Conditions:

Healthy

Hyperoxia

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Normobaric oxygen toxicity of the lung

In vivo antioxidant gene expression in human airway epithelium of normal individuals exposed to 100% O(2)

Pulmonary oxygen toxicity Early reversible changes in human alveolar structures induced by hyperoxia

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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