Clinical trial NCT01175174: Clinical, Airway Inflammatory, and HRA Phenotypes, in Preschool Children With Acute Asthmatic Attack Presenting to the ED.
Official title: Clinical, Airway Inflammatory, and HRA Phenotypes, in Preschool Children With Acute Asthmatic Attack Presenting to the ED.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
preschool children
adenosine provocation test
metacholine provocation test
pediatric emergency department
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children, age: 1-6 years old presenting to the emergency room (ER) with acute wheezing episode.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: airways inflammatory phenotype
timeFrame: Within 24 hours from admission to the emergency department (ED)
measure: post attack bronchial hyperreactivity to adenosine 5'-monophosphate and to metacholine
timeFrame: 1. Within 2 weeks of recruitment 2. After 3 moths from recruitment
Secondary outcomes:
measure: Relationship between post attack bronchial hyperreactivity to adenosine 5'-monophosphate and to metacholine and the response to treatment and cytologic phenotypes.
timeFrame: 1. Within 3 weeks of recruitment 2. Beyond 3 moths from recruitment
measure: relationship between cytologic phenotypes and response to treatment.
timeFrame: Within 3 months of recruitmant
measure: clinical phenotype
timeFrame: whithin 1 month of presentation
Other outcomes:
Locations:
city: Holon
country: Israel
facility: The Edith Wlofson Medical Center
Study officials:
affiliation: The Sackler School of Medicine, Tel Aviv University, Israel
name: Avigdor Mandelberg, MD
role: STUDY_CHAIR
References: