Inhaled Nanosilver Study

NCT02408874 | Withdrawn

• 2 other identifiers: 15010415-E-0104
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Nanoparticles; Inflammatory Response; Silver; Lung Function; Lung Microbiome

Outcome Measures

Primary Outcomes (1)

• To evaluate the impact of nanosilver exposure on ex vivo inflammatory response of bronchoscopy-derived cells (i.e. alveolar macrophage and epithelial cells) to challenge with a TLR agonist

  1 day post treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all of the following criteria for enrollment:
• Age 18 to 60 years (males and females)
• Able to understand and provide written consent
• Able to travel to the NIEHS CRU for required study visits
• Able to present a valid government-issued form of identification for entry to the NIEHS campus
• Able to fast for 6 hours prior to two visits where bronchoscopy occurs

You may not qualify if:

• Participants meeting any of the following criteria at screening will not be eligible for enrollment:
• Women who are pregnant or breastfeeding
• Current smoker or significant second-hand smoke exposure (defined by urine cotinine \>200 ng/mL at screening)
• Body Mass Index (BMI) \>35
• Significant sources of exposure to silver that, in the investigator's opinion, will compromise the integrity of the study assessments (e.g., regular use of silver-containing dietary supplements, homeopathic remedies, or cleaning products)
• FEV1 \<80% predicted; or, positive methacholine test \[i.e., provocative concentration of methacholine producing a 20% fall in FEV1 (PC20-FEV1) is reached at a solution of less than or equal to 4 mg/mL\]
• History of pulmonary or cardiovascular conditions, including the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (CF), non-CF bronchiectasis, pulmonary fibrosis, sarcoidosis, pulmonary hypertension, unstable angina
• Allergy or history of adverse reactions to metals
• Any condition that, in the investigator's opinion, places the patient at undue risk for complications associated with required study procedures
• Bleeding disorders
• Facial deformity, major facial surgery
• Allergy or history of adverse reactions to methacholine or lidocain (or other similar topical anesthetics)
• Body weight \<50 kg (\<110 lbs)
• The following abnormal lab values on the screening blood work:
• Platelet count \<100,000/microliters

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Officials

• Stavros Garantziotis, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 6, 2015
• Study Start: April 3, 2015
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: December 17, 2019

Record last verified: 2017-11-20