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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Hessen
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Frankfurt am Main, Hessen, Alemanha, 60596
- Children's Hospital, Goethe-University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Patients with Asthma
Affected patients -20 Patients suffering from asthma with an eNO over 30 bbp |
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Healthy Subjects
Non-affected patients -20 matched controls not suffering from asthma |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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cell count differences in induced sputum
Prazo: V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)
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Differences in neutrophils, macrophages and lymphocytes in subjects with and without asthma
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V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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differences in cell count depending on the method of sputum induction
Prazo: V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)
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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.
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V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FRA-AKAS
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