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| ID | Type | Description | Link |
|---|---|---|---|
| Eudra-CT Nr. 2005-005534-12 |
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House dust mite allergy is a common problem, resulting in asthma, chronic swelling of the eyes, and running nose. The investigators test a possibility to immunize subjects sensitized against house dust mite with extracts from their own gut bacteria "auto-vaccination".
see above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | house dust mite allergics will undergo autovaccine immunization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of autovaccine (Autovaccine Symbiopharm) | Biological | increasing dosage schedule, six different concentrations, application over six weeks, 2 weeks break, another six weeks, 2 weeks break, than challenge with inhalative house dust mite extract |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' clinical parameters and behaviour, laboratory values | jul 2006 - august 2008 | |
| laboratory testing reflecting function of bone marrow, liver, kidney | jul 2006- august 2008 |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function,exhalative NO | jul 2006 - oct 2007 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Zielen, M.D., Ph.D. | Goethe University, Department of pulmonology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goethe University, Department of Pulmonology | Frankfurt am Main | Hesse | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7967946 | Background | Halasa J. [Justification of treatment with autovaccine]. Med Dosw Mikrobiol. 1994;46(1-2 Suppl):5-9. No abstract available. Polish. | |
| 22989372 | Derived | Schulze J, Voss S, Zissler U, Rose MA, Zielen S, Schubert R. Airway responses and inflammation in subjects with asthma after four days of repeated high-single-dose allergen challenge. Respir Res. 2012 Sep 19;13(1):78. doi: 10.1186/1465-9921-13-78. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| 21639872 | Derived | Rose MA, Weigand B, Schubert R, Schulze J, Zielen S. Safety, tolerability, and impact on allergic inflammation of autologous E.coli autovaccine in the treatment of house dust mite asthma--a prospective open clinical trial. BMC Complement Altern Med. 2011 Jun 3;11:45. doi: 10.1186/1472-6882-11-45. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |