NCT00969670

Brief Summary

Samples of sputum from asthmatic children, between 5-17 years, will be collected during two years of the study period to perform tests Particle Size Distribution (PSD) and Shape Analysis (SA) of the particulate matter in the sputum and a biochemical reaction to evaluate the activity of Heme Oxygenase-1 protein in sputum cell supernatants. Each child will perform Pulmonary Function Testing (PFT) and Induced Sputum (IS) as a routine part of diagnosis of asthma. Parents will be asked to complete a questionnaire including questions on their child's respiratory symptoms in the last 12 months as well as socioeconomic factors. Parents will be asked to give informed written consent for their child's participation in the study.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

First QC Date

August 29, 2009

Last Update Submit

November 21, 2009

Conditions

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children, between 5-17 years, performing a routine diagnosis of asthma in Tel Aviv Sourasky Medical Center

You may qualify if:

  • All children, between 5-17 years, performing a routine diagnosis of asthma in Tel Aviv Sourasky Medical Center that there parents gave informed written consent for their child's participation in the study.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Laboratory of Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples of indused sputum

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 29, 2009

First Posted

September 1, 2009

Study Start

October 1, 2009

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations