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Cell Distribution in Induced Sputum in Patients With Asthma

29. juni 2012 opdateret af: Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospital

Cell Distribution in Induced Sputum in Healthy Subjects and Patients With Asthma After Different Techniques for Sputum Induction

The aim of this case-control study is the comparison of the cell distribution in induced sputum in young adults with asthma and in healthy controls.

The study consists of two visits. At both visits subjects are asked to perform a lung function test (body plethysmography) and levels of exhaled nitric oxide (eNO) are measured. At the first visit a blood sample is drawn to determine the inflammatory and allergic status of the subjects and the sputum is induced by an ultrasonic nebulizer. At the second visit another sputum sample is induced by a nozzle nebulizer. The cell distribution will be evaluated in both sputum samples.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Objectives:

The aim of this study is the characterization of healthy children/ young adults and matched patients with asthma in terms of lung function, and the degree of the systemic and bronchial inflammation.

Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (qRT-PCR) and by a cytometric bead assay (CBA). Components of the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant proteins) are determined from sputum or blood respectively.

Methods and Work Programme:

This study consists of two study visits (V1 and V2)

V1 (day 0 - duration 1 hour):

  • Measurement of exhaled nitric oxide (eNO)
  • Lung function testing with and body plethysmography
  • Blood test: blood count, CRP, RAST, serum inflammatory mediators, markers of the non-specific pulmonary defense system
  • Induced sputum attained by an ultrasonic-nebulizer for inflammatory mediators and microbiological investigations

V2 (day 14-28 - duration 1 hour):

  • Measurement of nitric oxide in expired air (eNO)
  • Lung function testing with spirometry and body plethysmography
  • Induced sputum attained by a nozzle-nebulizer for inflammatory mediators and microbiological investigations

Study population:

Children, adolescents and young people (6 - 25 years of age). Both the patients and the healthy subjects are recruited from the outpatient clinic of Pediatric Allergy and Pulmonology.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

40

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
    • Hessen
      • Frankfurt am Main, Hessen, Tyskland, 60596
        • Children's Hospital, Goethe-University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 25 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study is carried out in children, adolescents, and young adults (6 to 25 years of age). Both the patients (n=20) and the healthy subjects (n=20) are recruited from the outpatient clinic of the department of Pediatric Allergy and Pulmonology, University Clinic, Goethe-University, Frankfurt/M, Germany.

Beskrivelse

Inclusion Criteria:

  • informed consent
  • between 6 and 25 years of age
  • Known bronchial asthma/no bronchial asthma(depending on the study group)
  • Ability to perform lung function tests and inhalation

Exclusion Criteria:

  • < 6 and > 25 years of age
  • Any acute condition with systemic or bronchial inflammation
  • any chronic condition or infection (e.g. HIV, tuberculosis, malignancy)
  • pregnancy
  • known alcohol and/ or drug abuse
  • Inability to understand the extent and scope of the study
  • Participation in another study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Patients with Asthma

Affected patients

-20 Patients suffering from asthma with an eNO over 30 bbp
Healthy Subjects

Non-affected patients

-20 matched controls not suffering from asthma

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
cell count differences in induced sputum
Tidsramme: V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)
Differences in neutrophils, macrophages and lymphocytes in subjects with and without asthma
V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
differences in cell count depending on the method of sputum induction
Tidsramme: V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)
At V1 an ultrasonic nebulizer is used for sputum induction. At V2 a breath controlled nozzle nebulizer is used for sputum induction. These different techniques might lead to different cell counts in included subjects.
V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johann Wolfgang Goethe University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2011

Primær færdiggørelse (Faktiske)

1. maj 2012

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

20. februar 2012

Først indsendt, der opfyldte QC-kriterier

2. marts 2012

Først opslået (Skøn)

5. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. juli 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2012

Sidst verificeret

1. juni 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FRA-AKAS

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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