Bronchial AsthmaNCT00331929
Respiratory Health Study of Children in Kiryat Tivon
A study testing Minato A 500 AS spirometer in people with Bronchial Asthma and Signs and Symptoms, Respiratory, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in K. Tivon. The health status will be evaluated using health questionnaires and spirometry. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Bronchial Asthma, Signs and Symptoms, Respiratory, Allergy
- What is being tested?
- Minato A 500 AS spirometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 638 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2006to Dec 2007
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- All school children
Who cannot join
- Children that their parents did not signed the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in K. Tivon.
The health status will be evaluated using health questionnaires and spirometry.
Read the detailed description
Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in K. Tivon.
The health status will be evaluated while using health questionnaires and spirometry.
Objective: To evaluate the respiratory health of K. Tivon children with comparatives, with respect to local air pollution levels.
Material and Methods: All the school children from K. Tivon (1800 children) will be included in the study, after both parents and the children (above 12 years of age) will sign an informed consent form.
First step: A health questionnaire (based on Hebrew version of ISAAC questionnaire) will be filled in by the parents.
Second step: Spirometry checking of the children.
In parallel, air pollution levels will be measured and provided by a network of ground monitoring stations maintained by the Haifa District Municipality Association for the Environment (HDMAE). The station provides half-hourly measurement of mean concentrations of gaseous (NOX, SO2, O3) and particular (PM 10) pollutants over the entire investigation window. Additional meteorological data are also collected.
Risk maps: Using a GIS platform, we are developing a multi-layer risk mapping procedure which accounts for ambient concentrations of selected pollutants and the heterogenic spatial distribution of several demographic and socio-economic indexes in the region.
The prevalence of pulmonary disease will be evaluated according to the risk maps.
- Conditions
- Bronchial Asthma, Signs and Symptoms, Respiratory, Allergy
- Being tested
- Minato A 500 AS spirometer
- Keywords
- Asthma, Allergy, Respiratory, Pollution, Children, Air pollution
- Medical subject headings
- Asthma, Signs and Symptoms, Respiratory, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minato A 500 AS spirometerDevice
Also called Spirometer MINATOm AS 500 JAPAn
Spirometry at rest
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Cohort of school children that evaluated with questionnaire and spirometry with MINATO 500 JAPAN spirometer Receives: Device: Minato A 500 AS spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of respiratory symptoms in respect to air pollution
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchial AsthmaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 638 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Haim Bibi, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331929
- Sponsor's protocol ID
- Ped-2/2006
- Other IDs
- HTA 3653, CMC 06013904
- Status last verified
- Dec 2007
- First submitted
- 28 May 2006
- Last updated
- 20 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schwartz J. Air pollution and children's health. Pediatrics. 2004 Apr;113(4 Suppl):1037-43.
PubMed 15060197
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Health Study of Children in Kiryat Tivon
- ClinicalTrials.gov ID
- NCT00331929
- Acronym / sponsor ID
- Ped-2/2006
- Conditions
- Bronchial Asthma, Signs and Symptoms, Respiratory, Allergy
- Keywords
- Asthma, Allergy, Respiratory, Pollution, Children, Air pollution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 638 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 31 May 2006 (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.
Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in K. Tivon.
The health status will be evaluated using health questionnaires and spirometry.
Detailed description
Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in K. Tivon.
The health status will be evaluated while using health questionnaires and spirometry.
Objective: To evaluate the respiratory health of K. Tivon children with comparatives, with respect to local air pollution levels.
Material and Methods: All the school children from K. Tivon (1800 children) will be included in the study, after both parents and the children (above 12 years of age) will sign an informed consent form.
First step: A health questionnaire (based on Hebrew version of ISAAC questionnaire) will be filled in by the parents.
Second step: Spirometry checking of the children.
In parallel, air pollution levels will be measured and provided by a network of ground monitoring stations maintained by the Haifa District Municipality Association for the Environment (HDMAE). The station provides half-hourly measurement of mean concentrations of gaseous (NOX, SO2, O3) and particular (PM 10) pollutants over the entire investigation window. Additional meteorological data are also collected.
Risk maps: Using a GIS platform, we are developing a multi-layer risk mapping procedure which accounts for ambient concentrations of selected pollutants and the heterogenic spatial distribution of several demographic and socio-economic indexes in the region.
The prevalence of pulmonary disease will be evaluated according to the risk maps.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Minato A 500 AS spirometerCohort of school children that evaluated with questionnaire and spirometry with MINATO 500 JAPAN spirometer |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All school children
Key exclusion criteria (1 listed)
- Children that their parents did not signed the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minato A 500 AS spirometerAlso: Spirometer MINATOm AS 500 JAPAnSpirometry at rest | Device | A |
Primary outcome
The prevalence of respiratory symptoms in respect to air pollution
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2008.
- Background: PubMed 15060197Schwartz J. Air pollution and children's health. Pediatrics. 2004 Apr;113(4 Suppl):1037-43.
- air pollution and asthmaLink provided by the sponsor.
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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.
Haim Bibi, MD principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minato A 500 AS spirometer in people with Bronchial Asthma and Signs and Symptoms, Respiratory, run by Carmel 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jun 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The prevalence of respiratory symptoms in respect to air pollution (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00331929, which also lists 1 linked publication.
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 20 Jun 2008; AzTrials last refreshed its copy on 8 Nov 2026.