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

Primary Purpose

Bronchial Asthma, Signs and Symptoms, Respiratory, Allergy

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Spirometry (Pony spirometer)
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchial Asthma focused on measuring Asthma, Allergy, Respiratory, Pollution, Children, Air pollution

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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.

Sites / Locations

  • Schools at the Haifa Bay region, Israel.

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

School children from Haifa bay region, Israel.

Outcomes

Primary Outcome Measures

The prevalence of respiratory symptoms in respect to air pollution

Secondary Outcome Measures

Full Information

First Posted
July 17, 2008
Last Updated
September 13, 2010
Sponsor
Carmel Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00717899
Brief Title
The Effect of Air Pollution on Lung Health Among School Children Living in Haifa Bay Region
Official Title
The Effect of Air Pollution on Lung Health Among School Children Living in Haifa Bay Region
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Carmel Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma, Signs and Symptoms, Respiratory, Allergy
Keywords
Asthma, Allergy, Respiratory, Pollution, Children, Air pollution

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
School children from Haifa bay region, Israel.
Intervention Type
Device
Intervention Name(s)
Spirometry (Pony spirometer)
Other Intervention Name(s)
Pony spirometer, Cosmed, Italy
Intervention Description
Spirometry at rest
Primary Outcome Measure Information:
Title
The prevalence of respiratory symptoms in respect to air pollution
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Living in Haifa bay region, Israel. Parents signed informed consent. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haim Bibi, MD
Organizational Affiliation
Carmel Medical Center, Haifa, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schools at the Haifa Bay region, Israel.
City
Haifa Bay
Country
Israel

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/15060197?ordinalpos=6&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
Description
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The Effect of Air Pollution on Lung Health Among School Children Living in Haifa Bay Region

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