Study Results
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Basic Information
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UNKNOWN
NA
68 participants
INTERVENTIONAL
2021-08-01
2022-09-30
Brief Summary
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Detailed Description
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Besides these standard procedures the investigators want to investigate the micro-RNA profiles in two EIA subgroups: EIA with house-dust allergy (n = 24) and EIA without house-dust allergy (n = 24).
Both groups are characterized by different eNO levels. The patients with EIA and house-dust allergy should have an eNO \> 30 ppb, the patients with EIA without house-dust allergy an eNO \< 20 ppb.
The micro-RNA profiles of the both EIA subgroups will be compared the micro RNA profiles of 20 healthy controls .
Therefore blood will be taken (for a complete blood count and micro RNA analysis) at three points of time: before ECC, directly after ECC and after 24 hours ± 4 hours after ECC.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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EIA wih house dust mite
Patients with EIA and house-dust mite allergy and an eNO \> 30 ppb
Exercise challenge in the cold chamber (ECC)
Exercise challenge (defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber. Gradient: 10%, temperature 2-4°C. After the exercise challenge controlling bodyplethysmography and spirometry after 5, 10, 15 and 30 minutes. A positive reaction is a decrease of ≥ 10% of FEV1 in comparison to the initial value.
mRNA profile
Blood taking with full blood exam and PAXgene tube for investigation oft the micro RNA profiles. The PAXgene Blood RNA kit insulates total RNA inclusive miRNA and small RNA which are centrifugated, pelletised, washed and incubated to detach proteins. For mapping the particular miRNA there will be generated libraries with specifical codes to match the analysis to the original probe. Next generation sequencing will be performed by MISeq REagent Kit v3 and the analysis oft the different expressions in the R Version 3.2.3. The divergent expressions will be refurbished by computer and databased.
standard diagnostic
bodyplethysmography, spirometry, exhaled NO, skin prick test, asthma control test (ACT)
EIA without sensitization
Patients with EIA without allergic sensitization and an eNO \< 20 ppb
Exercise challenge in the cold chamber (ECC)
Exercise challenge (defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber. Gradient: 10%, temperature 2-4°C. After the exercise challenge controlling bodyplethysmography and spirometry after 5, 10, 15 and 30 minutes. A positive reaction is a decrease of ≥ 10% of FEV1 in comparison to the initial value.
mRNA profile
Blood taking with full blood exam and PAXgene tube for investigation oft the micro RNA profiles. The PAXgene Blood RNA kit insulates total RNA inclusive miRNA and small RNA which are centrifugated, pelletised, washed and incubated to detach proteins. For mapping the particular miRNA there will be generated libraries with specifical codes to match the analysis to the original probe. Next generation sequencing will be performed by MISeq REagent Kit v3 and the analysis oft the different expressions in the R Version 3.2.3. The divergent expressions will be refurbished by computer and databased.
standard diagnostic
bodyplethysmography, spirometry, exhaled NO, skin prick test, asthma control test (ACT)
Healthy controls
Healthy controls without allergic sensitization or known asthma
mRNA profile
Blood taking with full blood exam and PAXgene tube for investigation oft the micro RNA profiles. The PAXgene Blood RNA kit insulates total RNA inclusive miRNA and small RNA which are centrifugated, pelletised, washed and incubated to detach proteins. For mapping the particular miRNA there will be generated libraries with specifical codes to match the analysis to the original probe. Next generation sequencing will be performed by MISeq REagent Kit v3 and the analysis oft the different expressions in the R Version 3.2.3. The divergent expressions will be refurbished by computer and databased.
standard diagnostic
bodyplethysmography, spirometry, exhaled NO, skin prick test, asthma control test (ACT)
Interventions
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Exercise challenge in the cold chamber (ECC)
Exercise challenge (defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber. Gradient: 10%, temperature 2-4°C. After the exercise challenge controlling bodyplethysmography and spirometry after 5, 10, 15 and 30 minutes. A positive reaction is a decrease of ≥ 10% of FEV1 in comparison to the initial value.
mRNA profile
Blood taking with full blood exam and PAXgene tube for investigation oft the micro RNA profiles. The PAXgene Blood RNA kit insulates total RNA inclusive miRNA and small RNA which are centrifugated, pelletised, washed and incubated to detach proteins. For mapping the particular miRNA there will be generated libraries with specifical codes to match the analysis to the original probe. Next generation sequencing will be performed by MISeq REagent Kit v3 and the analysis oft the different expressions in the R Version 3.2.3. The divergent expressions will be refurbished by computer and databased.
standard diagnostic
bodyplethysmography, spirometry, exhaled NO, skin prick test, asthma control test (ACT)
Eligibility Criteria
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Inclusion Criteria
* age \>=12 and \<= 24
* known exercise induced asthma
* Group 1: skin prick test positiv house-dust allergy, eNO \> 30 ppb, MCT PD20 \< 0,1 mg
* Group 2: skin prick test negative house-dust allergy, eNO \< 20 ppb, MCT PD20 \< 1 mg
* lung function before ECC forced vital capacity (FVC) ≥ 75% and forced exspiratory pressure in one second (FEV1) ≥ 70%
* written agreement
* age \>=18 and \<= 24
Exclusion Criteria
* lung function FVC \< 75% und FEV1\< 70%
* inability to understand the range of the study
* chronic asthma with systemic cortisone therapy
* regular therapy with inhalative corticosteroids or leukotriene-antagonists \<14 days before visit 1
* intake of long acting beta-agonists (LABA) 48 h before examination
* intake of short acting beta-agonists (SABA) 8 h before examination
* acute severe infection (pneumonia) within the last 4 weeks
* other chronic diseases or infections (HIV, Tbc)
* pregnancy
For healthy controls
* age \< 18 and \> 24 years
* known asthma bronchiale or other chronic lung diseases
* lung function FVC \< 90% and FEV1 \< 80%
* allergic sensitization in skin prick test
* eNO \> 30 ppb
* inability to understand the range of the study
* acute severe infection (pneumonia) within the last 4 weeks
* other chronic diseases or infections (HIV, Tbc)
* pregnancy
12 Years
24 Years
ALL
Yes
Sponsors
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Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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Stefan Zielen
Prof. Dr. med.
Principal Investigators
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Melanie Dreßler, MD
Role: PRINCIPAL_INVESTIGATOR
Johann Wolfgang Goethe University Hospital
Locations
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Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Dressler M, Friedrich T, Lasowski N, Herrmann E, Zielen S, Schulze J. Predictors and reproducibility of exercise-induced bronchoconstriction in cold air. BMC Pulm Med. 2019 May 16;19(1):94. doi: 10.1186/s12890-019-0845-3.
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Schulze 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.
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.
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Other Identifiers
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E68/21
Identifier Type: -
Identifier Source: org_study_id
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