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In this study patients suffering from Immunoglobulin E (IgE) mediated asthma are treated with a method, called immune apheresis, that removes IgE from blood. In order to achieve this blood is taken continuously from the patient and then separated into plasma and blood cells by centrifuge. The plasma passes the new IgE adsorber where the IgE is specifically bound. The "cleaned" plasma re-joined with the blood cells is given back to the patient. In total each patient randomized to the apheresis group will undergo 3 treatments per week (i.e. 1 cycle) every 4 weeks over a time period of 3 months, that means 9 apheresis treatments in 3 cycles in total. Study hypothesis is that the new IgE adsorber is capable of reducing IgE in plasma/serum by at least 50% measured before the first treatment in the first cycle and after the last treatment in the last treatment cycle. The new adsorber can be safely used in patients. A group of patients with conventional drug treatment and no apheresis treatment serves as control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apheresis, IgE adsorber | Experimental | 9 apheresis treatments with the new IgE adsorber in a period of 3 months with 3 cycles of 3 treatments each every month. |
|
| Conventional drug treatment | No Intervention | Patients treated with conventional asthma treatment as prescribed before study entry. No intervention in prescription |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgE adsorber | Device | Two plasma volumes of each patient in the apheresis group will be treated per session |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of IgE concentration in Plasma/Serum | Decrease in IgE concentrations from before the first apheresis treatment (in the control group the first blood sampling) to after the last apheresis treatment after three months (in the control group last blood sampling after three months) | Before first treatment (baseline) to after the last of 9 treatments over a time period of 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Derfler, Prof. Dr. | Dep. of Internal Medicine III, Nephrology and Dialysis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna | Vienna | A-1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28254561 | Derived | Lupinek C, Derfler K, Lee S, Prikoszovich T, Movadat O, Wollmann E, Cornelius C, Weber M, Froschl R, Selb R, Blatt K, Smiljkovic D, Schoder V, Cervenka R, Plaichner T, Stegfellner G, Huber H, Henning R, Kozik-Jaromin J, Perkmann T, Niederberger V, Petkov V, Valent P, Gauly A, Leinenbach HP, Uhlenbusch-Koerwer I, Valenta R. Extracorporeal IgE Immunoadsorption in Allergic Asthma: Safety and Efficacy. EBioMedicine. 2017 Mar;17:119-133. doi: 10.1016/j.ebiom.2017.02.007. Epub 2017 Feb 12. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |