Bronchial Inflammation in Patients With Bronchiolithis Obliterans (FRABO-02)
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| First Received Date ICMJE | June 26, 2012 | ||||||||
| Last Updated Date | September 18, 2012 | ||||||||
| Start Date ICMJE | August 2012 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change of FEF75 over time [ Time Frame: V1: Day 1 - V2: Day 28-42 ] [ Designated as safety issue: No ] Look for changes/ variability of this lung function parameter |
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| Original Primary Outcome Measures ICMJE |
Change of FEF75 [ Time Frame: V1: Day 1 - V2: Day 28-42 ] [ Designated as safety issue: No ] Lung function parameter |
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| Change History | Complete list of historical versions of study NCT01633385 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||
| Brief Title ICMJE | Bronchial Inflammation in Patients With Bronchiolithis Obliterans | ||||||||
| Official Title ICMJE | Lung Function and Bronchial Inflammation in Patients With Bronchiolithis Obliterans | ||||||||
| Brief Summary | The investigators plan to study the variability of lung function parameters and bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 25 years compared with an age- and sex-matched control group. The investigators will perform a pulmonary function test (body plethysmography with TLCO), and measure the fraction of exhaled nitric oxide (eNO). Further a blood sample is drawn to determine the systemic inflammation. Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers. This investigation will be repeated after 4-6 weeks. The aim of this study is to define baseline values and the variability of possible outcome parameters for future interventional studies. |
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| Detailed Description | The purpose of this study is to characterize the variability of lung function values and bronchial inflammation of 20 Patients with Bronchiolitis obliterans aged between 6 up to 25 years. The patients' data will be compared with the results of a reference group with similar age conditions to determine possible outcome-parameters for following interventional studies. The sputum samples will be processed and quantitatively analyzed to get a profile of the cytological composition. (Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) and by cytometric bead assay (CBA).) Methods and Work Programme: This study consists of two study visits (V1 and V2) V1:
V2:
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Biospecimen | Retention: Samples With DNA Description: blood, sputum cells, sputum supernatans |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients suffering from Bronchiolitis obliterans and controls |
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| Condition ICMJE | Bronchiolitis Obliterans | ||||||||
| Intervention ICMJE | |||||||||
| Study Group/Cohort (s) |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 6 Years to 25 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01633385 | ||||||||
| Other Study ID Numbers ICMJE | BO2012-02 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr. med. Martin Rosewich, Johann Wolfgang Goethe University Hospitals | ||||||||
| Study Sponsor ICMJE | Johann Wolfgang Goethe University Hospitals | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | Johann Wolfgang Goethe University Hospitals | ||||||||
| Verification Date | September 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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