NCT00717899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

Enrollment Period

8 months

First QC Date

July 17, 2008

Last Update Submit

September 13, 2010

Conditions

Bronchial AsthmaSigns and Symptoms, RespiratoryAllergy

Keywords

AsthmaAllergyRespiratoryPollutionChildrenAir pollution

Outcome Measures

Primary Outcomes (1)

  • The prevalence of respiratory symptoms in respect to air pollution

    Two years

Study Arms (1)

1

ACTIVE COMPARATOR

School children from Haifa bay region, Israel.

Device: Spirometry (Pony spirometer)

Interventions

Spirometry (Pony spirometer)DEVICE

Spirometry at rest

Also known as: Pony spirometer, Cosmed, Italy
1

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schools at the Haifa Bay region, Israel.

Haifa Bay, Israel

Location

Related Links

MeSH Terms

Conditions

AsthmaSigns and Symptoms, RespiratoryHypersensitivity

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Haim Bibi, MD

    Carmel Medical Center, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 18, 2008

Study Start

December 1, 2008

Primary Completion

August 1, 2009

Study Completion

September 1, 2010

Last Updated

September 14, 2010

Record last verified: 2010-09

Locations

IL(1)