Cell Distribution in Induced Sputum in Patients With Asthma
|ClinicalTrials.gov Identifier: NCT01543516|
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : July 2, 2012
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.
|Condition or disease|
|Bronchial Asthma With eNO-levels Greater Than 30 ppB|
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
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.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Observational Model:||Case Control|
|Official Title:||Cell Distribution in Induced Sputum in Healthy Subjects and Patients With Asthma After Different Techniques for Sputum Induction|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2012|
Patients with Asthma
-20 Patients suffering from asthma with an eNO over 30 bbp
-20 matched controls not suffering from asthma
- cell count differences in induced sputum [ Time Frame: 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
- differences in cell count depending on the method of sputum induction [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543516
|Children's Hospital, Goethe-University|
|Frankfurt am Main, Hessen, Germany, 60596|