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

• ClinicalTrials.gov Identifier: NCT01175174
• Recruitment Status: Completed
• First Posted: August 4, 2010
• Last Update Posted: September 7, 2011
• Sponsor: Wolfson Medical Center
• Information provided by (Responsible Party): Avigdor Mandelberg, Wolfson Medical Center

Study Description

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.

Condition or disease
Asthma

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Time Perspective: Prospective
• Official Title: Clinical, Airway Inflammatory, and HRA Phenotypes, in Preschool Children With Acute Asthmatic Attack Presenting to the ED.
• Study Start Date: January 2009
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: September 2011

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. airways inflammatory phenotype [ Time Frame: Within 24 hours from admission to the emergency department (ED) ]
2. post attack bronchial hyperreactivity to adenosine 5'-monophosphate and to metacholine [ Time Frame: 1. Within 2 weeks of recruitment 2. After 3 moths from recruitment ]

Secondary Outcome Measures :

1. Relationship between post attack bronchial hyperreactivity to adenosine 5'-monophosphate and to metacholine and the response to treatment and cytologic phenotypes. [ Time Frame: 1. Within 3 weeks of recruitment 2. Beyond 3 moths from recruitment ]
2. relationship between cytologic phenotypes and response to treatment. [ Time Frame: Within 3 months of recruitmant ]
3. clinical phenotype [ Time Frame: whithin 1 month of presentation ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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

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

Contacts and Locations

Locations

Israel

The Edith Wlofson Medical Center

Holon, Israel

Sponsors and Collaborators

Wolfson Medical Center

Investigators

• Study Chair: Avigdor Mandelberg, MD; The Sackler School of Medicine, Tel Aviv University, Israel

More Information

• Responsible Party: Avigdor Mandelberg, Director, Pediatric Pulmonry Unit, Wolfson Medical Center
• ClinicalTrials.gov Identifier: NCT01175174
• Other Study ID Numbers: 1038-sputum
• First Posted: August 4, 2010
• Last Update Posted: September 7, 2011
• Last Verified: September 2011

Keywords provided by Avigdor Mandelberg, Wolfson Medical Center:

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

Additional relevant MeSH terms:

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