Cell Distribution in Induced Sputum in Patients With Asthma
Condition: Bronchial Asthma With eNO-levels Greater Than 30 ppB
MeSH terms: Asthma
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Biospecimen description: 
      whole blood, serum, and sputum
    
Keywords: Asthma; Sputum; Blood; Inflammation; adaptive immune system; innate immune system