Inflammatory DiseaseNCT02408874
Inhaled Nanosilver Study
An observational study of Inflammatory Disease, run by National Institute of Environmental Health Sciences (NIEHS).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Disease
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Apr 2015to 20 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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]
Show all 23Show fewer
- 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)
- Temperature >37.6 C, blood pressure <90/50 or >170/95 mmHg, or pulse rate <50 or >100 beats/minute (if in the investigator s clinical judgment, the exclusionary condition(s) may resolve, the candidate may be rescreened at a later date)
- Body weight <50 kg (<110 lbs)
- The following abnormal lab values on the screening blood work:
- Platelet count <100,000/microliters
- White blood cells count less than or equal to 1000/microliters
- Absolute neutrophil count less than or equal to 500/microliters
- Hematocrit <35% for both female and male
- Hemoglobin less than or equal to 9 g/dL
- Prothrombin Time (PT) / International Normalized Ratio (INR) greater than or equal to 1.3
- Activated partial prothromboplastin time (aPTT) greater than or equal to 40 seconds
- Serum creatinine greater than or equal to 1.4 mg/dL
About this study
Official title: Study to Assess the Impact of Inhaled Silver Nanoparticles on Lung Cell Immune Response
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.
Read more
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.
Read the detailed description
This is a single-center, single-arm pilot study to assess the impact of inhaled silver nanoparticles (nanosilver or nAg) on immune responses in the lung. Non-smoking, healthy adults (no lung or cardiovascular conditions), age 18-60 will be recruited to participate; pregnant or breastfeeding women will be excluded.
Potential participants will be prescreened by telephone and scheduled for a final eligibility visit that will include vital signs/anthropometry, medical/medication history review, physical exam, urine tests, blood draw, urine collection, and pulmonary function tests (PFTs; i.e., spirometry and methacholine challenge test). After eligibility is confirmed, the participant will be scheduled for a baseline visit, which includes vital signs/anthropometry, medical/medication history review, physical exam, blood draw, urine collection, and bronchoscopy (with lavage and brushing). Participants will return 14-40 days between the baseline visit and study treatment visit, which includes vital signs/anthropometry, blood draw, urine collection, spirometry, one-time administration of ionic silver via nebulizer, and instructions to collect urine for 24 hours. The next day after the study treatment visit, the participant will return for a visit that includes vital signs/anthropometry, blood draw, providing the 24-hour urine sample, spirometry, and bronchoscopy. During each bronchoscopy procedure, bronchoalveolar lavage (BAL) fluid and tissue from bronchial brushings will be collected from the participant to obtain alveolar macrophages and bronchial epithelial cells.
The primary objective of the study is to determine whether exposure to nanosilver alters the immune responses of lung cells. The primary laboratory analysis will determine whether exposure to nanosilver mediates a change from baseline in the response of bronchoscopy-derived, cultured macrophages or epithelial cells to challenge with a toll-like receptor (TLR) agonist. Additional analyses will assess changes in cytokine levels in BAL fluid, changes in the lung microbiome, silver penetration into the blood stream, silver excretion in the urine, and changes in PFT measures.
- Conditions
- Inflammatory Disease
- Keywords
- Nanoparticles, Inflammatory Response, Silver, Lung Function, Lung Microbiome
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study start3 Apr 2015
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stavros Garantziotis, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408874
- Sponsor's protocol ID
- 150104
- Other IDs
- 15-E-0104
- Status last verified
- 20 Nov 2017
- First submitted
- 3 Apr 2015
- Last updated
- 17 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Impact of Inhaled Silver Nanoparticles on Lung Cell Immune Response
- ClinicalTrials.gov ID
- NCT02408874
- Acronym / sponsor ID
- 150104
- Conditions
- Inflammatory Disease
- Keywords
- Nanoparticles, Inflammatory Response, Silver, Lung Function, Lung Microbiome
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 3 Apr 2015
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, single-arm pilot study to assess the impact of inhaled silver nanoparticles (nanosilver or nAg) on immune responses in the lung. Non-smoking, healthy adults (no lung or cardiovascular conditions), age 18-60 will be recruited to participate; pregnant or breastfeeding women will be excluded.
Potential participants will be prescreened by telephone and scheduled for a final eligibility visit that will include vital signs/anthropometry, medical/medication history review, physical exam, urine tests, blood draw, urine collection, and pulmonary function tests (PFTs; i.e., spirometry and methacholine challenge test). After eligibility is confirmed, the participant will be scheduled for a baseline visit, which includes vital signs/anthropometry, medical/medication history review, physical exam, blood draw, urine collection, and bronchoscopy (with lavage and brushing). Participants will return 14-40 days between the baseline visit and study treatment visit, which includes vital signs/anthropometry, blood draw, urine collection, spirometry, one-time administration of ionic silver via nebulizer, and instructions to collect urine for 24 hours. The next day after the study treatment visit, the participant will return for a visit that includes vital signs/anthropometry, blood draw, providing the 24-hour urine sample, spirometry, and bronchoscopy. During each bronchoscopy procedure, bronchoalveolar lavage (BAL) fluid and tissue from bronchial brushings will be collected from the participant to obtain alveolar macrophages and bronchial epithelial cells.
The primary objective of the study is to determine whether exposure to nanosilver alters the immune responses of lung cells. The primary laboratory analysis will determine whether exposure to nanosilver mediates a change from baseline in the response of bronchoscopy-derived, cultured macrophages or epithelial cells to challenge with a toll-like receptor (TLR) agonist. Additional analyses will assess changes in cytokine levels in BAL fluid, changes in the lung microbiome, silver penetration into the blood stream, silver excretion in the urine, and changes in PFT measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (23 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 1 day post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stavros Garantziotis, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Disease, run by National Institute of Environmental Health Sciences (NIEHS).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 day post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.