Cell Distribution in Induced Sputum in Patients With Asthma
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Purpose
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 |
|---|
|
Bronchial Asthma With eNO-levels Greater Than 30 ppB |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Cell Distribution in Induced Sputum in Healthy Subjects and Patients With Asthma After Different Techniques for Sputum Induction |
- 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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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
whole blood, serum, and sputum
| Enrollment: | 40 |
| Study Start Date: | November 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Patients with Asthma
Affected patients -20 Patients suffering from asthma with an eNO over 30 bbp |
|
Healthy Subjects
Non-affected patients -20 matched controls not suffering from asthma |
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.
Eligibility| Ages Eligible for Study: | 6 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. med. Martin Rosewich, Principal Investigator, Johann Wolfgang Goethe University Hospitals |
| ClinicalTrials.gov Identifier: | NCT01543516 History of Changes |
| Other Study ID Numbers: | FRA-AKAS |
| Study First Received: | February 20, 2012 |
| Last Updated: | June 29, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Johann Wolfgang Goethe University Hospitals:
|
Asthma Sputum Blood |
Inflammation adaptive immune system innate immune system |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on October 17, 2012
