Cell Distribution in Induced Sputum in Patients With Asthma
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.
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
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Hessen
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Frankfurt am Main, Hessen, Tyskland, 60596
- Children's Hospital, Goethe-University
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FRA-AKAS
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