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Inhaled Nanosilver Study

NCT02408874 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2019-12-17

No results posted yet for this study

Summary

Background:

\- Nanosilver is tiny silver particles. Many products contain nanosilver, like antimicrobial cleaning supplies and antimicrobial fabrics. Some products also contain nanosilver in a solution that people inhale. The companies that make these products claim they can help boost the immune system.

Objective:

\- To learn if inhaling nanosilver affects the lung s immune system. In addition, to see if nanosilver affects lung function and if it gets absorbed into the bloodstream after it is inhaled.

Eligibility:

\- Healthy, non-smoking adults ages 18 60.

Design:

* Participants will be pre-screened by phone.
* Participants will then be screened with a medical history and physical exam. They will give blood and urine samples.
* Participants will have lung function tests. They will breathe into a spirometer. It has a mouthpiece attached to a tube that is connected to a computer.
* Participants will have a methacholine challenge test. They will blow into a spirometer. Then they will inhale methacholine.
* Eligible participants will have 3 study visits over 2 5 weeks. At each visit, they will repeat some of the screening tests.
* At visit 1, participants will have a bronchoscopy. For this, an intravenous line is placed in an arm vein. Electrodes are placed on the chest. A tube is placed through the nose and into the airways. The airway is washed. A sample of cells is taken.
* At visit 2, participants will get the study treatment. They will inhale a nanosilver solution mist. They will have lung function tests before and after treatment.
* Participants will collect their urine from the time they get the treatment until they return to the clinic the next day.
* At visit 3, participants will turn in their urine. They will have another bronchoscopy.

Conditions

  • Inflammatory Disease

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    lead NIH

Principal Investigators

  • Stavros Garantziotis, M.D. · National Institute of Environmental Health Sciences (NIEHS)

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-03
Primary Completion
2017-11-20
Completion
2017-11-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02408874 on ClinicalTrials.gov