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

NCT01175174 | Completed

• 1 other identifier: 1038-sputum
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

asthma; preschool children; adenosine provocation test; metacholine provocation test; pediatric emergency department

Outcome Measures

Primary Outcomes (2)

• airways inflammatory phenotype

  Within 24 hours from admission to the emergency department (ED)

• post attack bronchial hyperreactivity to adenosine 5'-monophosphate and to metacholine

  1. Within 2 weeks of recruitment 2. After 3 moths from recruitment

Secondary Outcomes (3)

• 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

• relationship between cytologic phenotypes and response to treatment.

  Within 3 months of recruitmant

• clinical phenotype

  whithin 1 month of presentation

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children, age: 1-6 years old presenting to the emergency room (ER) with acute wheezing episode.

You may qualify if:

• children, age: 1-6 years old
• presenting to the ER with acute wheezing episode.

You may not qualify if:

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

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

The Edith Wlofson Medical Center

Holon, Israel

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Avigdor Mandelberg, MD

  The Sackler School of Medicine, Tel Aviv University, Israel

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Pulmonry Unit

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 4, 2010
• Study Start: January 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

IL (1)