Cystic Fibrosis, Clinical Trial
— ABPAOfficial title:
Clinical Presentation and Bronchial Inflammation of Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients With Cystic Fibrosis
| Verified date | October 2010 |
| Source | Johann Wolfgang Goethe University Hospitals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Observational |
Chronic bronchial inflammation is an important clinical feature in cystic fibrosis.
Approximately 10% of patients with cystic fibrosis suffer from Allergic Bronchopulmonary
Aspergillosis. In addition airway inflammation in patients with cystic fibrosis (CF) plays a
major role in progression of CF lung disease. In patients with mild disease (Vital capacity
>75%) airway inflammation is often under diagnosed.
Severity of allergy against Aspergillus fumigatus will be examined using radioallergosorbent
test and skin Prick-test. Subsequently, in patients with established sensitization (RAST ≥
0.35 IU/mL) a specific bronchial provocation with Aspergillus will be performed. In
addition, exhaled nitric oxide,carbon monoxide, exhaled air temperature and inflammatory
cells in sputum is measured. 24 hours after bronchial allergen provocation, exhaled NO, CO,
air temperature, and bronchial responsiveness is determined and a second sputum obtained.
This study is designed to characterize patients with CF and sensitization against
Aspergillus fumigatus in an early stage to prevent pulmonary complications of ABPA. In
addition sputum cytokine profiles in CF patients with mild and moderate disease may be
different in patients without and with involvement of small airway disease (SAD).
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | August 2010 |
| Est. primary completion date | May 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 4 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - informed consent - age between 4 and 45 years - well-known Cystic fibrosis - Lung function: FEV1 (% pred.) = 70% Exclusion Criteria: - age < 4 and > 45 years - lung function: FEV1 (% pred.)< 70% - other chronic diseases or infections (e.g., HIV, tuberculosis, malignancy) - pregnancy - known alcohol, drug and/or drug abuse - inability to capture the scale and scope of the study - participation in another study |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Germany | Goethe-University Hospital | Frankfurt | Hesse |
| Lead Sponsor | Collaborator |
|---|---|
| Johann Wolfgang Goethe University Hospitals |
Germany,
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* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The characterization of patients with CF and sensitization to Aspergillus fumigatus, and analyzing involvement of small airway disease (SAD) | 1 year | Yes | |
| Secondary | Aspergillus-induced inflammation in sputum using new mediators (IL-8, IL-13, TLR2 and TLR4, LBP and Chitinasen) with the quantitative PCR and protein assay analysis. | In addition planned data analyze: CF-patients will be divided according to their involvement of small airway disease (SAD) into 2 groups: Group 1 without SAD with MEF25 > 50%, Group 2 with SAD with MEF25 < 50% and cell counts and pro-inflammatory cytokines (IL-5, IL-6, IL-8, IL-13, IL-17, INF) measured by quantitative RT-PCR and protein assay will be analyzed. | 1 year | No |