AsthmaEHFNCT01754948
Biological Monitoring of Nano Sized Particles in the Airways of Asthmatic Children
An observational study of Asthma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Background Ambient airborne particulate material (PM) is defined according the aerodynamic diameter into coarse, fine, and ultrafine or "nano" sized particles ranging between 2.5-10 µm (coarse), <2.5 µm (fine), and <0.1 µm (nano(. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2012to Jun 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: asthmatic and control children
Who may be able to join
- age 6-18 years
- living in the Tel Aviv area
- referred to the pulmonology lab for respiratory function evaluation
Who cannot join
- Exposure to cigarette smoke
- Respiratory infection in the 4 weeks prior to recruitment and testing
Trial locations and contacts
1 site in 1 country.
Elizabeth Fireman, Phd contact
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Medical Center
Tel Aviv
Shira Benor, MD, shirabenor@yahoo.com
Shira Benor
About this study
Background Ambient airborne particulate material (PM) is defined according the aerodynamic diameter into coarse, fine, and ultrafine or "nano" sized particles ranging between 2.5-10 µm (coarse), <2.5 µm (fine), and <0.1 µm (nano(. Many studies have examined particle effect on respiratory health in children, mainly by environmental monitoring of coarse and fine particles. Biological assessment of individual exposure to nano sized particles in correlation to adverse health effect was not previously studied.
Hypothesis individual exposure to nano sized particles in children is associated with reduction in forced expiratory volume at one second.
- Conditions
- Asthma
- Keywords
- asthma, reactive airway disease, cough, air pollution, nano particles
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Cough
What is being measured
The primary outcome is the main question the study is designed to answer.
spirometry values
forced expiratory volume at one second
Measured: 1 sec
Secondary outcomes (1)
methacholine and adenosine challenge test results
provocative concentration causing a 20% fall in forced expiratory volume at one second and provocative dose causing a 20% fall in forced expiratory volume at one second
Measured: 1 sec
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shira Benor, MD, Study director, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754948
- Sponsor's protocol ID
- 0488
- Acronym
- EHF
- Status last verified
- Dec 2012
- First submitted
- 18 Dec 2012
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Monitoring of Nano Sized Particles in the Airways of Asthmatic Children
- ClinicalTrials.gov ID
- NCT01754948
- Acronym / sponsor ID
- EHF / 0488
- Conditions
- Asthma
- Keywords
- asthma, reactive airway disease, cough, air pollution, nano particles
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 21 Dec 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.
Background Ambient airborne particulate material (PM) is defined according the aerodynamic diameter into coarse, fine, and ultrafine or "nano" sized particles ranging between 2.5-10 µm (coarse), <2.5 µm (fine), and <0.1 µm (nano(. Many studies have examined particle effect on respiratory health in children, mainly by environmental monitoring of coarse and fine particles. Biological assessment of individual exposure to nano sized particles in correlation to adverse health effect was not previously studied.
Hypothesis individual exposure to nano sized particles in children is associated with reduction in forced expiratory volume at one second.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- asthmatic and control children
Key inclusion criteria (3 listed)
- age 6-18 years
- living in the Tel Aviv area
- referred to the pulmonology lab for respiratory function evaluation
Key exclusion criteria (2 listed)
- Exposure to cigarette smoke
- Respiratory infection in the 4 weeks prior to recruitment and testing
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
spirometry values
Time frame: 1 sec
forced expiratory volume at one second
1 secondary outcome
methacholine and adenosine challenge test results
Time frame: 1 sec
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
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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.
Elizabeth Fireman, Phd contact
Shira Benor, MD study director
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Shira Benor, MD (+972527360276, shirabenor@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spirometry values (time frame: 1 sec). 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 21 Dec 2012.