CClinicalTrials.gg
CompletedNCT00718133Updated Sep 14, 2010

The Effect of Air Pollution on Lung Health Among Children Living in Haifa Bay Region, Israel

An interventional study of Spirometry (Pony spirometer) in Bronchial Asthma, Signs and Symptoms, Respiratory and Allergy, sponsored by Carmel Medical Center. Completed at 1 site in Israel. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-09-14.

Sponsored by Carmel Medical Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

Haifa bay region 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 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.

02

Conditions studied

  • Bronchial Asthma
  • Signs and Symptoms, Respiratory
  • Allergy

Keywords

  • Asthma
  • Allergy
  • Respiratory
  • Pollution
  • Children
  • Air pollution
03

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 15 is below the median of 83 across 2,751 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Carmel Medical Center is the lead sponsor of 112 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Living in Haifa bay region, Israel.
  • Parents signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    1

    Children at school age from Haifa bay region

    Device: Spirometry (Pony spirometer)

Interventions

  • DeviceSpirometry (Pony spirometer)

    Spirometry at rest

    Also known as: Pony spirometer, Cosmed, Italy.

06

What researchers measure

Primary outcomes

  1. The prevalence of respiratory symptoms in respect to air pollution

    Time frame: Two years

07

Study locations

1 site
  • Pediatric Center Armon Clinic
    Haifa, 34362, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00718133
Lead sponsor
Carmel Medical Center
First posted
Jul 18, 2008
Start date
Dec 2008
Primary completion
Aug 2009
Completion
Sep 2010
Last update
Sep 14, 2010

Study contacts

Haim Bibi, MD
principal investigator · Carmel Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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