Clinical, Airway Inflammatory, and HRA Phenotypes, in Preschool Children With Acute Asthmatic Attack Presenting to the ED.

Asthma Clinical Trial

Official title:

Clinical, Airway Inflammatory, and HRA Phenotypes, in Preschool Children With Acute Asthmatic Attack Presenting to the ED.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01175174
• Other study ID #: 1038-sputum
• Status: Completed
• Phase: N/A
• First received: August 2, 2010
• Last updated: September 4, 2011
• Start date: January 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial Summary

Clinical, Airway Inflammatory, and HRA Phenotypes, in preschool children with acute asthmatic attack presenting to the ED.

Background:

Children under the age of 5 years have the highest hospitalization rate of asthma. The most common causes of acute exacerbations of asthma requiring urgent medical care are viral respiratory infections. Most of these children < 6 y old are not atopic.

The inflammatory response to these mostly viral-induced asthmatic attacks is not well characterized in the literature. Moreover it is not known whether different kind of inflammatory responses exist in this population and how this correlate to clinical outcomes and clinical phenotypes in preschool children presenting ti the ED with acute asthmatic attack.

Therefore, the purpose of the present study is to:

Investigate the characterization of induced sputum cytology in preschool children with acute asthmatic attack and whether there is correlation between specific sputum cytology and response to therapy and to investigate airways hyper-responsiveness to adenosine 5'-monophosphate and to metacholine in pre school children 2-6 y old at 2 weeks and at 3 month following acute asthmatic exacerbation and look for correlation with response to treatment and sputum cytology. Clinical phenotypes of this patient population will also be investigated.

Description:

Clinical, Airway Inflammatory, and HRA Phenotypes, in preschool children with acute asthmatic attack presenting to the ED.

Background:

Children under the age of 5 years have the highest hospitalization rate of asthma. The most common causes of acute exacerbations of asthma requiring urgent medical care are viral respiratory infections. Most of these children < 6 y old are not atopic.

The inflammatory response to these mostly viral-induced asthmatic attacks is not well characterized in the literature. Moreover it is not known whether different kind of inflammatory responses exist in this population and how this correlate to clinical outcomes and clinical phenotypes.

Therefore, the purpose of the present study is to:

Investigate the characterization of induced sputum cytology, bronchial hyper-responsiveness (BHR, and clinical phenotypes in preschool children with acute asthmatic attack presenting to the ED and whether there is correlation between specific sputum cytology and response to therapy.

and to investigate airways hyper-responsiveness (BHR)to adenosine 5'-monophosphate and to metacholine in pre school children 2-6 y old at 2 weeks and at 3 month following acute asthmatic exacerbation and look for correlation with response to treatment and sputum cytology.

Clinical phenotypes of this patient population will also be investigated.Clinical characteristics of the preschool children presenting to the ED with asthmatic attack will be compared to normal controls recruited from ambulatory clinics at the same area.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 6 Years

Eligibility

Inclusion Criteria:

• children, age: 1-6 years old

• presenting to the ER with acute wheezing episode.

Exclusion Criteria:

• Any chronic (lung, cardiac, immunologic, neurologic) disease

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Israel	The Edith Wlofson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	airways inflammatory phenotype		Within 24 hours from admission to the emergency department (ED)	No
Primary	post attack bronchial hyperreactivity to adenosine 5'-monophosphate and to metacholine		1. Within 2 weeks of recruitment 2. After 3 moths from recruitment	No
Secondary	Relationship between post attack bronchial hyperreactivity to adenosine 5'-monophosphate and to metacholine and the response to treatment and cytologic phenotypes.		1. Within 3 weeks of recruitment 2. Beyond 3 moths from recruitment	No
Secondary	relationship between cytologic phenotypes and response to treatment.		Within 3 months of recruitmant	No
Secondary	clinical phenotype	Clinical characteristics of the preschool children presenting to the ED with asthmatic attack will be compared to mormal controls recruited from ambulatory clinics at the same area.	whithin 1 month of presentation	No