Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy

Allergic Asthma Clinical Trial

— ITASIT  

Official title:

Security of the Bronchial Allergen Provocation With Mite and Aspergillus and Predictors for a Positive Reaction.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479205
• Other study ID #: FRAITASIT
• Status: Completed
• Phase: N/A
• First received: November 22, 2011
• Last updated: November 23, 2011
• Start date: July 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

One aim of this study was to find out if the bronchial allergen provocation (BAP) is an appropriate method to appraise the efficacy of a specific immunotherapy (SIT). The investigators had one group of children receiving SIT and one group of patients who denied a SIT although they had an indication for it. Retrospectively the investigators analysed the data of the first BAP and blood parameters specific IgE-mite, total IgE before SIT (November 2008 till February 2010). Prospectively The investigators analysed the lung parameters and allergic labor parameters that we got in the course of the second BAP. The investigators mean parameter was PD20FEV1-mite. Another aim of The investigators study was to find specific immunological differences between children who improved because of SIT and those who showed no improvement. Thus, The investigators compared the levels of total IgE, cumulative IgE-mite and specific IgE-mite before and after SIT and the levels of specific IgG-mite and specific IgG4-mite after SIT.

Description:

One aim of this study was to find out if the bronchial allergen provocation(BAP) is an appropriate method to appraise the efficacy of a specific immunotherapy (SIT). We had one group of children receiving SIT and one group of patients who denied a SIT although they had an indication for it. Retrospectively we analysed the data of the first BAP (PD20FEV1, VC, FEV1, FEV1/VC (%), eNO) and allergic blood parameters like specific IgE-mite, total IgE, cumulative IgE before SIT (November 2008 till February 2010). Prospectively we analysed the lung parameters and allergic labor parameters that we got in the course of the second BAP. Our mean parameter was PD20FEV1-mite. Another aim of our study was to find specific immunological differences between children who improved because of SIT and those who showed no improvement. Thus, we compared the levels of total IgE, cumulative IgE-mite and specific IgE-mite before and after SIT and the levels of specific IgG-mite and specific IgG4-mite after SIT. Additionally all patients answered a questionnaire according to ISAAC about their clinical symptoms, their quality of life and their medication score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• informed consent

• between 5 and 18 years of age

• diagnosis of a moderate Asthma bronchiale (I-II) in the last 12 months or rhino conjunctivitis

• no exacerbation > 4 weeks before Visit

Exclusion Criteria:

• age < 5 years > 18 years,

• FEV1 < 75%

• no cooperation to undergo the BAP,

• exacerbation within the last 28 days before Visit

• other serious illnesses

• taking part in other clinical trials < 30 days

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Asthma
• Mite Allergy

Locations

Country	Name	City	State
Germany	Department of Paediatric Allergy and Pulmonology	Frankfurt (Main)

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Abramson MJ, Puy RM, Weiner JM. Injection allergen immunotherapy for asthma. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD001186. doi: 10.1002/14651858.CD001186.pub2. Review. — View Citation

Blumberga G, Groes L, Dahl R. SQ-standardized house dust mite immunotherapy as an immunomodulatory treatment in patients with asthma. Allergy. 2011 Feb;66(2):178-85. doi: 10.1111/j.1398-9995.2010.02451.x. Epub 2010 Sep 30. — View Citation

Pfaar O, Robinson DS, Sager A, Emuzyte R. Immunotherapy with depigmented-polymerized mixed tree pollen extract: a clinical trial and responder analysis. Allergy. 2010 Dec;65(12):1614-21. doi: 10.1111/j.1398-9995.2010.02413.x. — View Citation

Rosewich M, Schulze J, Eickmeier O, Telles T, Rose MA, Schubert R, Zielen S. Tolerance induction after specific immunotherapy with pollen allergoids adjuvanted by monophosphoryl lipid A in children. Clin Exp Immunol. 2010 Jun;160(3):403-10. doi: 10.1111/j — View Citation

Schubert R, Eickmeier O, Garn H, Baer PC, Mueller T, Schulze J, Rose MA, Rosewich M, Renz H, Zielen S. Safety and immunogenicity of a cluster specific immunotherapy in children with bronchial asthma and mite allergy. Int Arch Allergy Immunol. 2009;148(3): — View Citation

Schulze J, Rosewich M, Dressler M, Riemer C, Rose MA, Zielen S. Bronchial allergen challenge using the Medicaid dosimeter. Int Arch Allergy Immunol. 2012;157(1):89-97. doi: 10.1159/000324473. Epub 2011 Sep 7. — View Citation

Zielen S, Christmann M, Kloska M, Dogan-Yildiz G, Lieb A, Rosewich M, Schubert R, Rose MA, Schulze J. Predicting short term response to anti-inflammatory therapy in young children with asthma. Curr Med Res Opin. 2010 Feb;26(2):483-92. doi: 10.1185/0300799 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in BAP	significant improvement of PD20FEV1-mite in BAP	one year after initiation of SIT	No
Secondary	Improvement of quality of life and medication	Via questionnaire (adapted from ISAAC-study) we assessed the quality of life, clinical symptoms and medication scores of the patients included	1 year after initiation of SIT	No