An observational study in Bronchial Asthma With eNO-levels Greater Than 30 ppB, sponsored by Johann Wolfgang Goethe University Hospital. Completed at 1 site in Germany. Open to participants aged 6 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-02.
Sponsored by Johann Wolfgang Goethe University Hospital · Observational
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.
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):
V2 (day 14-28 - duration 1 hour):
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 40 is below the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Johann Wolfgang Goethe University Hospital is the lead sponsor of 158 studies on the registry; 8 are open to participants now.
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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.
Exclusion Criteria:
Affected patients -20 Patients suffering from asthma with an eNO over 30 bbp
Non-affected patients -20 matched controls not suffering from asthma
cell count differences in induced sputum
Differences in neutrophils, macrophages and lymphocytes in subjects with and without asthma
Time frame: V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)
differences in cell count depending on the method of sputum induction
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.
Time frame: V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour)
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Johann Wolfgang Goethe University Hospital