Inadequate or Impaired Respiratory FunctionNanoexposureNCT01599845
The Differential Pattern of Deposition of Nano Particles in the Airways of Exposed Workers
An observational study of Inadequate or Impaired Respiratory Function, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Investigation of the differences between the levels of extracellular and intracellular nano-particles in workers exposed to environmental particles during their employment to enhance understanding the process of penetration of the particles to respiratory epithelial cells. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inadequate or Impaired Respiratory Function
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2012to May 2013
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients
Who may be able to join
- Adults over 20 years of age who visit Ichilov Hospital for medical complaints/inquiries regarding respiratory tract.
- Study population is composed of people who are exposed to environmental particles form industrial sources.
- Informed consent is requested from each subject.
Who cannot join
- Unemployed individuals.
- Individuals who are not working in industrial jobs, such as office workers and secretaries.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Differential Pattern of Deposition of Nano Particles in the Airways of Exposed Workers (Nanoexposure)
Investigation of the differences between the levels of extracellular and intracellular nano-particles in workers exposed to environmental particles during their employment to enhance understanding the process of penetration of the particles to respiratory epithelial cells.
Read the detailed description
This study investigates the following questions:
Does occupational exposure to nanoparticles influence permeation of such particles to respiratory airways? Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and their pulmonary functions.
Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and respiratory tract infections.
The study protocol includes the following steps:
Initial interview of the patient Measurement of nanoparticles in samples of exhaled breath condensate using NanoSight LM 20 Measurement of nanoparticles in induced sputum. And finally examination of the relationship between the measured parameters and the indices of pulmonary infection, and pulmonary function as measured by the pulmonary department of the TASMC.
- Keywords
- Lung, Alveoli, Nanoparticles, Particulate matter, Exhaled breath condensate, Induced sputum, Forced expiratory volume, Force vital capacity
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nanoparticle exposed | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the size distribution of nano-particles in exhaled breath condensate
Each subject will be examined once. The total time for collection of data is estimated as about one year.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inadequate or Impaired Respiratory FunctionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yehuda Schwarz, M.D., Principal investigator, Tel Aviv Sourasky Medical Center (TASMC, Ichilov)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599845
- Sponsor's protocol ID
- TASMC-11-YS-0107-CTIL
- Acronym
- Nanoexposure
- Status last verified
- May 2012
- First submitted
- 29 Apr 2012
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differential Pattern of Deposition of Nano Particles in the Airways of Exposed Workers (Nanoexposure)
- ClinicalTrials.gov ID
- NCT01599845
- Acronym / sponsor ID
- Nanoexposure / TASMC-11-YS-0107-CTIL
- Keywords
- Lung, Alveoli, Nanoparticles, Particulate matter, Exhaled breath condensate, Induced sputum, Forced expiratory volume, Force vital capacity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- May 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 16 May 2012 (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.
Investigation of the differences between the levels of extracellular and intracellular nano-particles in workers exposed to environmental particles during their employment to enhance understanding the process of penetration of the particles to respiratory epithelial cells.
Detailed description
This study investigates the following questions:
Does occupational exposure to nanoparticles influence permeation of such particles to respiratory airways? Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and their pulmonary functions.
Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and respiratory tract infections.
The study protocol includes the following steps:
Initial interview of the patient Measurement of nanoparticles in samples of exhaled breath condensate using NanoSight LM 20 Measurement of nanoparticles in induced sputum. And finally examination of the relationship between the measured parameters and the indices of pulmonary infection, and pulmonary function as measured by the pulmonary department of the TASMC.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nanoparticle exposed | – | – |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients
Key inclusion criteria (3 listed)
- Adults over 20 years of age who visit Ichilov Hospital for medical complaints/inquiries regarding respiratory tract.
- Study population is composed of people who are exposed to environmental particles form industrial sources.
- Informed consent is requested from each subject.
Key exclusion criteria (2 listed)
- Unemployed individuals.
- Individuals who are not working in industrial jobs, such as office workers and secretaries.
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
Analysis of the size distribution of nano-particles in exhaled breath condensate
Time frame: One year
Each subject will be examined once. The total time for collection of data is estimated as about one year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
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.
Yehuda Schwarz, M.D. principal investigator
Tel Aviv Sourasky Medical Center (TASMC, Ichilov)
Questions about this trial
What is this clinical trial studying?
An observational study of Inadequate or Impaired Respiratory Function, run by Tel-Aviv Sourasky Medical Center.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 May 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yehuda Schwarz, M.D. (03-6973774, schwarz.reot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the size distribution of nano-particles in exhaled breath condensate (time frame: One year). 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 16 May 2012.