Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2026-02-28 @ 11:18 AM
Study NCT ID:
NCT01543516
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
2012-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cell Distribution in Induced Sputum in Patients With Asthma
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Study Overview
Official Title:
Cell Distribution in Induced Sputum in Healthy Subjects and Patients With Asthma After Different Techniques for Sputum Induction
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: