Bronchial AsthmaNCT00717899
The Effect of Air Pollution on Lung Health Among School Children Living in Haifa Bay Region
A study testing Spirometry (Pony spirometer) in people with Bronchial Asthma and Signs and Symptoms, Respiratory, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Haifa bay region is located close to a major industrial zone. The aim of the study is to evaluate the health status of school children living in Haifa bay region.The health status will be evaluated using health questionnaires and spirometry. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchial Asthma, Signs and Symptoms, Respiratory, Allergy
- What is being tested?
- Spirometry (Pony spirometer)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Sep 2010
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Living in Haifa bay region, Israel.
- Parents signed informed consent.
Who cannot join
- Children that their parents did not signed the informed consent
- Chronic disease except of asthma: Diabetes mellitus, Cystic Fibrosis, Cardiac diseases, Renal, Rheumatic and Chronic Gastrointestinal diseases, Mental retardation.
Trial locations and contacts
1 site in 1 country.
About this study
Haifa bay region is located close to a major industrial zone. The aim of the study is to evaluate the health status of school children living in Haifa bay region.The health status will be evaluated using health questionnaires and spirometry.
Read the detailed description
Haifa bay is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in Haifa bay region.
The health status will be evaluated while using health questionnaires and spirometry.
Objective: To evaluate the respiratory health of Haifa bay region children with comparatives, with respect to local air pollution levels.
Material and Methods: Children from Haifa bay region from 10 different communities (1200 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 The health status of the children will be documented from the children's primary clinic files as well.
- Conditions
- Bronchial Asthma, Signs and Symptoms, Respiratory, Allergy
- Being tested
- Spirometry (Pony 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.
Spirometry (Pony spirometer)Device
Also called Pony spirometer, Cosmed, Italy
Spirometry at rest
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | School children from Haifa bay region, Israel. Receives: Device: Spirometry (Pony 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: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startDec 2008
- Primary completionAug 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Haim Bibi, MD, Principal investigator, Carmel Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717899
- Sponsor's protocol ID
- HTA 4642/ CMC 0064-07
- Other IDs
- 3000004504 (Grant)
- Status last verified
- Sep 2010
- First submitted
- 17 Jul 2008
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Air Pollution on Lung Health Among School Children Living in Haifa Bay Region
- ClinicalTrials.gov ID
- NCT00717899
- Acronym / sponsor ID
- HTA 4642/ CMC 0064-07
- Conditions
- Bronchial Asthma, Signs and Symptoms, Respiratory, Allergy
- Keywords
- Asthma, Allergy, Respiratory, Pollution, Children, Air pollution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 18 Jul 2008 (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.
Haifa bay region is located close to a major industrial zone. The aim of the study is to evaluate the health status of school children living in Haifa bay region.The health status will be evaluated using health questionnaires and spirometry.
Detailed description
Haifa bay is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in Haifa bay region.
The health status will be evaluated while using health questionnaires and spirometry.
Objective: To evaluate the respiratory health of Haifa bay region children with comparatives, with respect to local air pollution levels.
Material and Methods: Children from Haifa bay region from 10 different communities (1200 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 The health status of the children will be documented from the children's primary clinic files as well.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Spirometry (Pony spirometer)School children from Haifa bay region, Israel. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Living in Haifa bay region, Israel.
- Parents signed informed consent.
Key exclusion criteria (2 listed)
- Children that their parents did not signed the informed consent
- Chronic disease except of asthma: Diabetes mellitus, Cystic Fibrosis, Cardiac diseases, Renal, Rheumatic and Chronic Gastrointestinal diseases, Mental retardation.
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 |
|---|---|---|
| Spirometry (Pony spirometer)Also: Pony spirometer, Cosmed, ItalySpirometry at rest | Device | 1 |
Primary outcome
The prevalence of respiratory symptoms in respect to air pollution
Time frame: Two 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 14 Sep 2010.
- Related InfoLink 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, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometry (Pony 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 2 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: finished, as of the sponsor's last update on 14 Sep 2010. 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: Two years). 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 14 Sep 2010.