Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: August 1995
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: August 27, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: August 22, 1995

Actual date on which the first participant was enrolled.

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.

NCT00001464
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: August 27, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

77 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

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: 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center