Bronchial Asthma With eNO-levels Greater Than 30 ppB Clinical Trial
Official title:
Cell Distribution in Induced Sputum in Healthy Subjects and Patients With Asthma After Different Techniques for Sputum Induction
| Verified date | June 2012 |
| Source | Johann Wolfgang Goethe University Hospitals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | 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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | June 2012 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 6 Years to 25 Years |
| Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Germany | Children's Hospital, Goethe-University | Frankfurt am Main | Hessen |
| Lead Sponsor | Collaborator |
|---|---|
| Johann Wolfgang Goethe University Hospitals |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | cell count differences in induced sputum | Differences in neutrophils, macrophages and lymphocytes in subjects with and without asthma | V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour) | No |
| Secondary | 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. | V1 and V2 respectively (V1 (day 0 - duration 1 hour) V2 (day 14-28 - duration 1 hour) | No |