Mite AllergyITASITNCT01479205
Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy
An observational study of Mite Allergy and Allergic Asthma, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Mite Allergy, Allergic Asthma
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 6-17 years of age with house dust mite allergy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Paediatric Allergy and Pulmonology
Frankfurt am Main, 60590
About this study
Official title: Security of the Bronchial Allergen Provocation With Mite and Aspergillus and Predictors for a Positive Reaction.
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.
Read the detailed 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.
- Conditions
- Mite Allergy, Allergic Asthma
- Keywords
- specific immunotherapy, bronchial allergen provocation, specific IgE, specific IgG, specific IgG4, SIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mite allergic patients without SIT | patients suffering from allergic asthma/ rhino-conjunctivitis denying specific immunotherapy | |
| mite allergic patients with SIT | patients suffering from allergic asthma/ rhino-conjunctivitis undergoing mite specific immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in BAP
significant improvement of PD20FEV1-mite in BAP
Measured: one year after initiation of SIT
Secondary outcomes (1)
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
Measured: 1 year after initiation of SIT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startJul 2010
- Primary completionNov 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mite AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Zielen, Johann Wolfgang Goethe University Hospital
- Investigators
- Stefan Zielen, Prof., Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479205
- Sponsor's protocol ID
- FRAITASIT
- Acronym
- ITASIT
- Status last verified
- Nov 2011
- First submitted
- 22 Nov 2011
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Abramson MJ, Puy RM, Weiner JM. Injection allergen immunotherapy for asthma. Cochrane Database Syst Rev. 2010 Aug 4;2010(8):CD001186. doi: 10.1002/14651858.CD001186.pub2.
PubMed 20687065Pfaar 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.
PubMed 20645937Blumberga 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.
PubMed 20883456Schulze 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.
PubMed 21912178Zielen 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: 10.1185/03007990903485148.
PubMed 20001651Schubert 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):251-60. doi: 10.1159/000161585. Epub 2008 Oct 10.
PubMed 18849616Rosewich 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.1365-2249.2010.04106.x. Epub 2010 Mar 16.
PubMed 20345983
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Security of the Bronchial Allergen Provocation With Mite and Aspergillus and Predictors for a Positive Reaction.
- ClinicalTrials.gov ID
- NCT01479205
- Acronym / sponsor ID
- ITASIT / FRAITASIT
- Conditions
- Mite Allergy, Allergic Asthma
- Keywords
- specific immunotherapy, bronchial allergen provocation, specific IgE, specific IgG, specific IgG4, SIT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mite allergic patients without SIT | – | –patients suffering from allergic asthma/ rhino-conjunctivitis denying specific immunotherapy |
| mite allergic patients with SIT | – | –patients suffering from allergic asthma/ rhino-conjunctivitis undergoing mite specific immunotherapy |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 6-17 years of age with house dust mite allergy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- age < 5 years > 18 years,
- FEV1 < 75%
- no cooperation to undergo the BAP,
- exacerbation within the last 28 days before Visit
- other serious illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
improvement in BAP
Time frame: one year after initiation of SIT
significant improvement of PD20FEV1-mite in BAP
1 secondary outcome
Improvement of quality of life and medication
Time frame: 1 year after initiation of SIT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2011.
- Background: PubMed 20687065Abramson MJ, Puy RM, Weiner JM. Injection allergen immunotherapy for asthma. Cochrane Database Syst Rev. 2010 Aug 4;2010(8):CD001186. doi: 10.1002/14651858.CD001186.pub2.
- Background: PubMed 20645937Pfaar 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.
- Background: PubMed 20883456Blumberga 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.
- Background: PubMed 21912178Schulze 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.
- Results publication: PubMed 20001651Zielen 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: 10.1185/03007990903485148.
- Results publication: PubMed 18849616Schubert 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):251-60. doi: 10.1159/000161585. Epub 2008 Oct 10.
- Results publication: PubMed 20345983Rosewich 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.1365-2249.2010.04106.x. Epub 2010 Mar 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Zielen, Prof. principal investigator
Johann Wolfgang Goethe University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mite Allergy and Allergic Asthma, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in BAP (time frame: one year after initiation of SIT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01479205, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2011.