Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

4 september 2011 uppdaterad av: Avigdor Mandelberg, Wolfson Medical Center

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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

30

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Holon, Israel
        • The Edith Wlofson Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 år till 6 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studiestol: Avigdor Mandelberg, MD, The Sackler School of Medicine, Tel Aviv University, Israel

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2009

Primärt slutförande (Faktisk)

1 juli 2011

Avslutad studie (Faktisk)

1 september 2011

Studieregistreringsdatum

Först inskickad

2 augusti 2010

Först inskickad som uppfyllde QC-kriterierna

2 augusti 2010

Första postat (Uppskatta)

4 augusti 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

7 september 2011

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 september 2011

Senast verifierad

1 september 2011

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

3
Prenumerera