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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01175174
First Posted: August 4, 2010
Last Update Posted: September 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Avigdor Mandelberg, Wolfson Medical Center
  Purpose

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
Asthma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical, Airway Inflammatory, and HRA Phenotypes, in Preschool Children With Acute Asthmatic Attack Presenting to the ED.

Resource links provided by NLM:


Further study details as provided by Avigdor Mandelberg, Wolfson Medical Center:

Primary Outcome Measures:
  • airways inflammatory phenotype [ Time Frame: Within 24 hours from admission to the emergency department (ED) ]
  • 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:
  • 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 ]
  • relationship between cytologic phenotypes and response to treatment. [ Time Frame: Within 3 months of recruitmant ]
  • 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.


Enrollment: 30
Study Start Date: January 2009
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175174


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     History of Changes
Other Study ID Numbers: 1038-sputum
First Submitted: August 2, 2010
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