House Dust Mite AllergyNCT01134757
Safety of Bronchial Allergen Challenge and Predictors for Positive Reaction.
A study testing house dust mite and alternaria allergen bronchial challenge in people with House Dust Mite Allergy and Bronchial Hyperresponsiveness, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The present study is aimed to evaluate a bronchial allergen challenge with house dust mite and alternaria. Firstly, the years 2005, 2006, 2007, 2008 and 2009 will be retrospectively reviewed. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- House Dust Mite Allergy, Bronchial Hyperresponsiveness
- What is being tested?
- house dust mite and alternaria allergen bronchial challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Oct 2012
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed consent
- Age between 5 and 18 years
- Known house dust mite or alternaria allergy
Who cannot join
- Age < 5 years and > 18 years
- Lung function VC < 80 % and FEV1 < 75 %
- Others chronic diseases or infections (e.g., HIV, tuberculosis, malignancy)
- Pregnancy
- Treatment with systemic corticosteroids
- Documented alcohol, substance, and/or drug abuse
- Incapability to perform all study procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective and Prospective, Diagnostic, Open-label, Single-center Study of the Safety of the Bronchial Allergen Challenge With House Dust Mite, Grass Pollen and Alternaria and Predictors for Positive Reaction.
The present study is aimed to evaluate a bronchial allergen challenge with house dust mite and alternaria. Firstly, the years 2005, 2006, 2007, 2008 and 2009 will be retrospectively reviewed. Secondly, in 2010-2013, in the prospective part of the study the patients will undergo the bronchial allergen challenge to examine safety of the bronchial allergen challenge and change of allergen specific bronchial hyperreactivity before and after allergen specific immunotherapy.
Read the detailed description
Specific bronchial allergen challenge is an established tool in clinical practice and research, supporting the understanding of pathophysiology of allergic asthma, and analysing the efficacy of new therapies. However, in preschool age there is only a few data about specific bronchial allergen challenges. Douglas (1) evaluated the predictors of positive response to bronchial allergic challenges with house dust mite and grass pollen in twelve 5-to 6-year-old atopic children. The most statistically significant predictors were the extent of atopy proven by skin prick testing, specific IgE, symptoms of asthma, and persistent atopic eczema. However, the number of patients was small. Therefore, more research is needed to confirm these findings. Further, the nonspecific bronchial hyperreactivity was found to have a high positive predictive value for positive reactions (2). To our best knowledge, this aspect is not investigated in children.
This study examines retro- and prospectively the safety of a bronchial allergic challenge with house dust mite, grass pollen and alternaria. The retrospective part will evaluate the associations of early allergic reaction, skin prick testing, specific IgE, measurement of exhaled NO, spirometry/IOS and bronchial methacholine challenge. The prospective part will measure the early allergic reaction (EAR) and focus on the late allergic reaction (LAR)and examine the change of allergen specific bronchial hyperreactivity before and after allergen specific immunotherapy. The study consists of two visits in the first year of the study and one follow-up visit per year. At first visit, all the patients undergo skin prick testing, measurement of exhaled NO, spirometry/IOS and bronchial methacholine challenge. At next visit specific bronchial allergen challenge will be performed and a blood sample will be taken. After that, each patient will measure hourly the peak flow during the next 10-hours. This procedure will be repeated after the first and second year of allergen specific immunotherapy. The safety issue of the study will be published separately. The change of the allergen specific bronchial hyperreactivity will be evaluated after every year of the study.
- Being tested
- house dust mite and alternaria allergen bronchial challenge
- Keywords
- EAR, LAR, BHR, house dust mite, alternaria
- Medical subject headings
- Dust Mite Allergy, Bronchial Hyperreactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
house dust mite and alternaria allergen bronchial challengeBiological
Also called Lyophylised allergen (Allergopharma, Rheinbeck, Germany)
2 ml of saline-dissolved lyophylised house dust mite or alternaria in concentration 5000 standard biological units (SBU/ml) The challenge is the only intervention. dosed in 6 steps of 5, 10, 20, 40, 80, and 160 SBU. 10 minutes after each step up a spirometry will be performed the challenge will be stopped in case of a ≥ 20% decrease from baseline in FEV1 (PD20) and 0,2 mg Salbutamol will be given.
| Study group | Role | What they receive |
|---|---|---|
| house dust mite and alternaria allergy | Other | As the intervention patients with house dust mite or alternaria allergy will undergo a bronchial allergen challenge with mite or alternaria extract. The early asthmatic response (EAR) and the late asthmatic response (LAR) will be measured before and after one year of allergen specific immunotherapy. Except of the challenge no further interventions are planned. Receives: Biological: house dust mite and alternaria allergen bronchial challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of bronchial allergen challenge with house dust mite and alternaria.
Early Allergic Reaction (EAR) and Late Allergic Reaction (LAR) will be monitored.
Measured: 10 hours
Secondary outcomes (2)
Correlation of predictors like skin prick testing, specific IgE, total IgE, allergen specific dose to PD20 FEV1, nonspecific hyperresponsiveness to methacholine and exhaled NO.
Statistical correlation of skin prick test results and allergen specific IgE
Measured: two weeks
Development of allergen specific bronchial hyperreactivity before and after SIT
Results of methacholine testing before and after specific immunotherapy
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for House Dust 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Schulze MD, Johann Wolfgang Goethe University Hospital
- Investigators
- Johannes Schulze, Dr., Principal investigator, Goethe University, Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134757
- Sponsor's protocol ID
- KGU-17/10
- Status last verified
- Mar 2023
- First submitted
- 1 Jun 2010
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Douglas TA, Kusel M, Pascoe EM, Loh RK, Holt PG, Sly PD. Predictors of response to bronchial allergen challenge in 5- to 6-year-old atopic children. Allergy. 2007 Apr;62(4):401-7. doi: 10.1111/j.1398-9995.2007.01329.x.
PubMed 17362251Cockcroft DW, Murdock KY, Kirby J, Hargreave F. Prediction of airway responsiveness to allergen from skin sensitivity to allergen and airway responsiveness to histamine. Am Rev Respir Dis. 1987 Jan;135(1):264-7. doi: 10.1164/arrd.1987.135.1.264.
PubMed 3800152Schulze J, Rosewich M, Riemer C, Dressler M, Rose MA, Zielen S. Methacholine challenge--comparison of an ATS protocol to a new rapid single concentration technique. Respir Med. 2009 Dec;103(12):1898-903. doi: 10.1016/j.rmed.2009.06.007. Epub 2009 Jul 10.
PubMed 19596563Rosewich M, Rose MA, Eickmeier O, Travaci M, Kitz R, Zielen S. Montelukast as add-on therapy to beta-agonists and late airway response. Eur Respir J. 2007 Jul;30(1):56-61. doi: 10.1183/09031936.00063106. Epub 2007 Feb 14.
PubMed 17301091Schulze J, Reinmuller W, Herrmann E, Rosewich M, Rose MA, Zielen S. Bronchial allergen challenges in children - safety and predictors. Pediatr Allergy Immunol. 2013 Feb;24(1):19-27. doi: 10.1111/pai.12031.
PubMed 23331526
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective and Prospective, Diagnostic, Open-label, Single-center Study of the Safety of the Bronchial Allergen Challenge With House Dust Mite, Grass Pollen and Alternaria and Predictors for Positive Reaction.
- ClinicalTrials.gov ID
- NCT01134757
- Acronym / sponsor ID
- KGU-17/10
- Keywords
- EAR, LAR, BHR, house dust mite, alternaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 2 Jun 2010 (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.
The present study is aimed to evaluate a bronchial allergen challenge with house dust mite and alternaria. Firstly, the years 2005, 2006, 2007, 2008 and 2009 will be retrospectively reviewed. Secondly, in 2010-2013, in the prospective part of the study the patients will undergo the bronchial allergen challenge to examine safety of the bronchial allergen challenge and change of allergen specific bronchial hyperreactivity before and after allergen specific immunotherapy.
Detailed description
Specific bronchial allergen challenge is an established tool in clinical practice and research, supporting the understanding of pathophysiology of allergic asthma, and analysing the efficacy of new therapies. However, in preschool age there is only a few data about specific bronchial allergen challenges. Douglas (1) evaluated the predictors of positive response to bronchial allergic challenges with house dust mite and grass pollen in twelve 5-to 6-year-old atopic children. The most statistically significant predictors were the extent of atopy proven by skin prick testing, specific IgE, symptoms of asthma, and persistent atopic eczema. However, the number of patients was small. Therefore, more research is needed to confirm these findings. Further, the nonspecific bronchial hyperreactivity was found to have a high positive predictive value for positive reactions (2). To our best knowledge, this aspect is not investigated in children.
This study examines retro- and prospectively the safety of a bronchial allergic challenge with house dust mite, grass pollen and alternaria. The retrospective part will evaluate the associations of early allergic reaction, skin prick testing, specific IgE, measurement of exhaled NO, spirometry/IOS and bronchial methacholine challenge. The prospective part will measure the early allergic reaction (EAR) and focus on the late allergic reaction (LAR)and examine the change of allergen specific bronchial hyperreactivity before and after allergen specific immunotherapy. The study consists of two visits in the first year of the study and one follow-up visit per year. At first visit, all the patients undergo skin prick testing, measurement of exhaled NO, spirometry/IOS and bronchial methacholine challenge. At next visit specific bronchial allergen challenge will be performed and a blood sample will be taken. After that, each patient will measure hourly the peak flow during the next 10-hours. This procedure will be repeated after the first and second year of allergen specific immunotherapy. The safety issue of the study will be published separately. The change of the allergen specific bronchial hyperreactivity will be evaluated after every year of the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| house dust mite and alternaria allergy | Other | Biological: house dust mite and alternaria allergen bronchial challengeAs the intervention patients with house dust mite or alternaria allergy will undergo a bronchial allergen challenge with mite or alternaria extract. The early asthmatic response (EAR) and the late asthmatic response (LAR) will be measured before and after one year of allergen specific immunotherapy. Except of the challenge no further interventions are planned. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Informed consent
- Age between 5 and 18 years
- Known house dust mite or alternaria allergy
Key exclusion criteria (7 listed)
- Age < 5 years and > 18 years
- Lung function VC < 80 % and FEV1 < 75 %
- Others chronic diseases or infections (e.g., HIV, tuberculosis, malignancy)
- Pregnancy
- Treatment with systemic corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| house dust mite and alternaria allergen bronchial challengeAlso: Lyophylised allergen (Allergopharma, Rheinbeck, Germany)2 ml of saline-dissolved lyophylised house dust mite or alternaria in concentration 5000 standard biological units (SBU/ml) The challenge is the only intervention. dosed in 6 steps of 5, 10, 20, 40, 80, and 160 SBU. 10 minutes after each step up a spirometry will be performed the challenge will be stopped in case of a ≥ 20% decrease from baseline in FEV1 (PD20) and 0,2 mg Salbutamol will be given. | Biological | house dust mite and alternaria allergy |
Primary outcome
Safety of bronchial allergen challenge with house dust mite and alternaria.
Time frame: 10 hours
Early Allergic Reaction (EAR) and Late Allergic Reaction (LAR) will be monitored.
2 secondary outcomes
Correlation of predictors like skin prick testing, specific IgE, total IgE, allergen specific dose to PD20 FEV1, nonspecific hyperresponsiveness to methacholine and exhaled NO.
Time frame: two weeks
Development of allergen specific bronchial hyperreactivity before and after SIT
Time frame: two weeks
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 13 Mar 2023.
- Background: PubMed 17362251Douglas TA, Kusel M, Pascoe EM, Loh RK, Holt PG, Sly PD. Predictors of response to bronchial allergen challenge in 5- to 6-year-old atopic children. Allergy. 2007 Apr;62(4):401-7. doi: 10.1111/j.1398-9995.2007.01329.x.
- Background: PubMed 3800152Cockcroft DW, Murdock KY, Kirby J, Hargreave F. Prediction of airway responsiveness to allergen from skin sensitivity to allergen and airway responsiveness to histamine. Am Rev Respir Dis. 1987 Jan;135(1):264-7. doi: 10.1164/arrd.1987.135.1.264.
- Background: PubMed 19596563Schulze J, Rosewich M, Riemer C, Dressler M, Rose MA, Zielen S. Methacholine challenge--comparison of an ATS protocol to a new rapid single concentration technique. Respir Med. 2009 Dec;103(12):1898-903. doi: 10.1016/j.rmed.2009.06.007. Epub 2009 Jul 10.
- Background: PubMed 17301091Rosewich M, Rose MA, Eickmeier O, Travaci M, Kitz R, Zielen S. Montelukast as add-on therapy to beta-agonists and late airway response. Eur Respir J. 2007 Jul;30(1):56-61. doi: 10.1183/09031936.00063106. Epub 2007 Feb 14.
- Results publication: PubMed 23331526Schulze J, Reinmuller W, Herrmann E, Rosewich M, Rose MA, Zielen S. Bronchial allergen challenges in children - safety and predictors. Pediatr Allergy Immunol. 2013 Feb;24(1):19-27. doi: 10.1111/pai.12031.
Related trials for House Dust Mite Allergy
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic
RecruitingObservational study
The Efficacy of Specific Immunotherapy Guided by Component-Resolved Diagnosis for Dust Mite Allergens in Chinese Pediatric Patients With Rhinitis and/or Asthma
Allergic Rhinitis Due to House Dust Mite
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.
Johannes Schulze, Dr. principal investigator
Goethe University, Frankfurt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing house dust mite and alternaria allergen bronchial challenge in people with House Dust Mite Allergy and Bronchial Hyperresponsiveness, 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 3 inclusion and 7 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 13 Mar 2023. 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?
Safety of bronchial allergen challenge with house dust mite and alternaria. (time frame: 10 hours). 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 NCT01134757, which also lists 5 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 13 Mar 2023.