Exercise Induced AsthmaNCT05174689
Epigenetic Regulation of Exercise Induced Asthma
A study testing Exercise challenge in the cold chamber (ECC), mRNA profile and standard diagnostic in people with Exercise Induced Asthma and House Dust Mite Allergy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The purpose of this study is to investigate the micro ribonucleic acid (mRNA) profiles of patients with EIA without allergic sensitization and EIA with house dust mite sensitization compared to that of healthy controls. Read more about this study
- Who is it for?
- Ages 12 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Induced Asthma, House Dust Mite Allergy
- What is being tested?
- Exercise challenge in the cold chamber (ECC), mRNA profile and standard diagnostic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2021to Sep 2022
- 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 12 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- written agreement
- 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
Who cannot join
- age < 12 und > 24 years
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590
Melanie Dreßler, MD, +49-69-6301-4588, melanie.dressler@kgu.de
Helena Donath, MD, +49-69-6301-4588, helena.donath@kgu.de
About this study
Official title: Epigenetic Regulation of Excercise Induced Asthma
The purpose of this study is to investigate the micro ribonucleic acid (mRNA) profiles of patients with EIA without allergic sensitization and EIA with house dust mite sensitization compared to that of healthy controls.
Read the detailed description
Patients with known EIA are periodically reexamined by medical history, clinical examination, bodyplethysmography, spirometry, exhaled nitric oxide (eNO), skin prick test, methacholin challenge test and exercise-challenge in a cold-chamber at 2-4°C (ECC). Additionally the investigators gathers the questionnaires: Asthma Control Test (ACT) and Dyspnoe Index (DI).
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
- Exercise Induced Asthma, House Dust Mite Allergy
- Being tested
- Exercise challenge in the cold chamber (ECC), mRNA profile, standard diagnostic
- Keywords
- Exercise Induced Asthma, eNO, exercise challenge, micro RNAs
- Medical subject headings
- Asthma, Exercise-Induced, Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise challenge in the cold chamber (ECC)Diagnostic test
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 profileDiagnostic test
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 diagnosticDiagnostic test
bodyplethysmography, spirometry, exhaled NO, skin prick test, asthma control test (ACT)
| Study group | Role | What they receive |
|---|---|---|
| EIA wih house dust mite | Other | Patients with EIA and house-dust mite allergy and an eNO > 30 ppb Receives: Diagnostic Test: Exercise challenge in the cold chamber (ECC); Diagnostic Test: mRNA profile; Diagnostic Test: standard diagnostic |
| EIA without sensitization | Other | Patients with EIA without allergic sensitization and an eNO < 20 ppb Receives: Diagnostic Test: Exercise challenge in the cold chamber (ECC); Diagnostic Test: mRNA profile; Diagnostic Test: standard diagnostic |
| Healthy controls | Other | Healthy controls without allergic sensitization or known asthma Receives: Diagnostic Test: mRNA profile; Diagnostic Test: standard diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysregulation of miRNA-146
The primary endpoint is the dysregulation of miRNA-146 in comparison to the control group and within the subgroups which play an determined role in the bronchial inflammation.
Therefore the total RNA, including miRNA, will be isolated using the PAXgene Blood miRNA Kit (Qiagen, Hilden, Germany). Concentration of RNA will be assessed using Nanodrop Lite spectrometry (Thermo Scientific, Dreieich, Germany). MiRNA libraries are generated with the QIAseq miRNA Library Kit (Qiagen, Hilden, Germany). Next generation sequencing (NGS) will be performed with the MiSeq Reagent Kit v3, the PhiX Sequencing Control v3 and the MiSeq™ Desktop Sequencer (all Illumina Inc., San Diego, CA, USA). Differential expression analysis will be performed in RStudio 1.2.1335 (https://cran.r-project.org/). False discovery rate correction will be applied and miRNAs are considered to be differentially expressed with p < 0.05.
Measured: 1 Year
Secondary outcomes (8)
Dysregulation miRNAs affecting Th2 mediated bronchial inflammation (miRNA-126, miRNA-21, miRNA-145, let7-mimic)
Dysregulation of other miRNAs affecting the Th2 mediated bronchial inflammation (miRNA-126, miRNA-21, miRNA-145, let7-mimic) and compare to the control group.
MiRNA preparation and measurement processes are described in Outcome 1.
Measured: 1 Year
Cange of eNO
Change of eNO after ECC in the EIA subgroups compared to the healthy controls
Measured: 1 Year
Change of leucocytes and neutrophile granulocytes
Change of leucocytes and neutrophile granulocytes after ECC in the EIA subgroups compared to the healthy controls
Measured: 1 Year
FEV1-decrease in ECC
Comparison of the FEV1-decrease in ECC with significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Measured: 1 Year
Comparison eNO with significant dysregulated miRNA
Comparison of the initial value of exhaled NO with significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Measured: 1 Year
Comparison of change of leucocytes and neutrophile granulocytes with significant dysregulated miRNA
Comparison of the increase of leucocytes and neutrophile granulocytes after ECC significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Measured: 1 Year
Comparison of ACT with significant dysregulated miRNA
Comparison of the score in ACT with significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Measured: 1 Year
Comparison of DI with significant dysregulated miRNA
Comparison of the scoresin DI with significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start1 Aug 2021
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Exercise Induced AsthmaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The micro RNA profile of patients with known EIA and house dust mite allergy and patients with EIA without allergic sensitization are compared to the micro RNA profile of healthy controls
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
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
- Melanie Dreßler, MD, Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174689
- Sponsor's protocol ID
- E68/21
- Status last verified
- Dec 2021
- First submitted
- 30 Aug 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parsons JP, Hallstrand TS, Mastronarde JG, Kaminsky DA, Rundell KW, Hull JH, Storms WW, Weiler JM, Cheek FM, Wilson KC, Anderson SD; American Thoracic Society Subcommittee on Exercise-induced Bronchoconstriction. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction. Am J Respir Crit Care Med. 2013 May 1;187(9):1016-27. doi: 10.1164/rccm.201303-0437ST.
PubMed 23634861Dressler 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.
PubMed 31097027Dressler M, Salzmann-Manrique E, Zielen S, Schulze J. Exhaled NO as a predictor of exercise-induced asthma in cold air. Nitric Oxide. 2018 Jun 1;76:45-52. doi: 10.1016/j.niox.2018.03.004. Epub 2018 Mar 8.
PubMed 29526567Schulze J, Smith HJ, Fuchs J, Herrmann E, Dressler M, Rose MA, Zielen S. Methacholine challenge in young children as evaluated by spirometry and impulse oscillometry. Respir Med. 2012 May;106(5):627-34. doi: 10.1016/j.rmed.2012.01.007. Epub 2012 Feb 10.
PubMed 22326606Schulze 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 19596563Schulze 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 21912178Schulze 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.
PubMed 22989372Anderson SD, Charlton B, Weiler JM, Nichols S, Spector SL, Pearlman DS; A305 Study Group. Comparison of mannitol and methacholine to predict exercise-induced bronchoconstriction and a clinical diagnosis of asthma. Respir Res. 2009 Jan 23;10(1):4. doi: 10.1186/1465-9921-10-4.
PubMed 19161635Driessen JM, van der Palen J, van Aalderen WM, de Jongh FH, Thio BJ. Inspiratory airflow limitation after exercise challenge in cold air in asthmatic children. Respir Med. 2012 Oct;106(10):1362-8. doi: 10.1016/j.rmed.2012.06.017. Epub 2012 Jul 11.
PubMed 22789953Zielen S, Lieb A, De La Motte S, Wagner F, de Monchy J, Fuhr R, Munzu C, Koehne-Voss S, Riviere GJ, Kaiser G, Erpenbeck VJ. Omalizumab protects against allergen- induced bronchoconstriction in allergic (immunoglobulin E-mediated) asthma. Int Arch Allergy Immunol. 2013;160(1):102-10. doi: 10.1159/000339243. Epub 2012 Aug 28.
PubMed 22948442Rosewich M, Zissler UM, Kheiri T, Voss S, Eickmeier O, Schulze J, Herrmann E, Ducker RP, Schubert R, Zielen S. Airway inflammation in children and adolescents with bronchiolitis obliterans. Cytokine. 2015 May;73(1):156-62. doi: 10.1016/j.cyto.2014.10.026. Epub 2015 Mar 6.
PubMed 25748838Jerkic SP, Michel F, Donath H, Herrmann E, Schubert R, Rosewich M, Zielen S. Calprotectin as a New Sensitive Marker of Neutrophilic Inflammation in Patients with Bronchiolitis Obliterans. Mediators Inflamm. 2020 May 1;2020:4641585. doi: 10.1155/2020/4641585. eCollection 2020.
PubMed 32410855Fussbroich D, Kohnle C, Schwenger T, Driessler C, Ducker RP, Eickmeier O, Gottwald G, Jerkic SP, Zielen S, Kreyenberg H, Beermann C, Chiocchetti AG, Schubert R. A combination of LCPUFAs regulates the expression of miRNA-146a-5p in a murine asthma model and human alveolar cells. Prostaglandins Other Lipid Mediat. 2020 Apr;147:106378. doi: 10.1016/j.prostaglandins.2019.106378. Epub 2019 Nov 4.
PubMed 31698144Tan Z, Randall G, Fan J, Camoretti-Mercado B, Brockman-Schneider R, Pan L, Solway J, Gern JE, Lemanske RF, Nicolae D, Ober C. Allele-specific targeting of microRNAs to HLA-G and risk of asthma. Am J Hum Genet. 2007 Oct;81(4):829-34. doi: 10.1086/521200. Epub 2007 Aug 20.
PubMed 17847008Zhang YY, Zhong M, Zhang MY, Lv K. [Expression and clinical significance of miR-155 in peripheral blood CD4(+);T cells of patients with allergic asthma]. Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2012 May;28(5):540-3. Chinese.
PubMed 22558995
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Regulation of Excercise Induced Asthma
- ClinicalTrials.gov ID
- NCT05174689
- Acronym / sponsor ID
- E68/21
- Conditions
- Exercise Induced Asthma, House Dust Mite Allergy
- Keywords
- Exercise Induced Asthma, eNO, exercise challenge, micro RNAs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 3 Jan 2022 (actual)
- 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 purpose of this study is to investigate the micro ribonucleic acid (mRNA) profiles of patients with EIA without allergic sensitization and EIA with house dust mite sensitization compared to that of healthy controls.
Detailed description
Patients with known EIA are periodically reexamined by medical history, clinical examination, bodyplethysmography, spirometry, exhaled nitric oxide (eNO), skin prick test, methacholin challenge test and exercise-challenge in a cold-chamber at 2-4°C (ECC). Additionally the investigators gathers the questionnaires: Asthma Control Test (ACT) and Dyspnoe Index (DI).
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The micro RNA profile of patients with known EIA and house dust mite allergy and patients with EIA without allergic sensitization are compared to the micro RNA profile of healthy controls
| Arm | Type | Receives |
|---|---|---|
| EIA wih house dust mite | Other | Diagnostic Test: Exercise challenge in the cold chamber (ECC), Diagnostic Test: mRNA profile, Diagnostic Test: standard diagnosticPatients with EIA and house-dust mite allergy and an eNO > 30 ppb |
| EIA without sensitization | Other | Diagnostic Test: Exercise challenge in the cold chamber (ECC), Diagnostic Test: mRNA profile, Diagnostic Test: standard diagnosticPatients with EIA without allergic sensitization and an eNO < 20 ppb |
| Healthy controls | Other | Diagnostic Test: mRNA profile, Diagnostic Test: standard diagnosticHealthy controls without allergic sensitization or known asthma |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- written agreement
- 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
Key exclusion criteria (20 listed)
- age < 12 und > 24 years
- 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
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 |
|---|---|---|
| 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. | Diagnostic test | EIA wih house dust mite, EIA without sensitization |
| mRNA profileBlood 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. | Diagnostic test | EIA wih house dust mite, EIA without sensitization, Healthy controls |
| standard diagnosticbodyplethysmography, spirometry, exhaled NO, skin prick test, asthma control test (ACT) | Diagnostic test | EIA wih house dust mite, EIA without sensitization, Healthy controls |
Primary outcome
Dysregulation of miRNA-146
Time frame: 1 Year
The primary endpoint is the dysregulation of miRNA-146 in comparison to the control group and within the subgroups which play an determined role in the bronchial inflammation. Therefore the total RNA, including miRNA, will be isolated using the PAXgene Blood miRNA Kit (Qiagen, Hilden, Germany). Concentration of RNA will be assessed using Nanodrop Lite spectrometry (Thermo Scientific, Dreieich, Germany). MiRNA libraries are generated with the QIAseq miRNA Library Kit (Qiagen, Hilden, Germany). Next generation sequencing (NGS) will be performed with the MiSeq Reagent Kit v3, the PhiX Sequencing Control v3 and the MiSeq™ Desktop Sequencer (all Illumina Inc., San Diego, CA, USA). Differential expression analysis will be performed in RStudio 1.2.1335 (https://cran.r-project.org/). False discovery rate correction will be applied and miRNAs are considered to be differentially expressed with p < 0.05.
8 secondary outcomes
Dysregulation miRNAs affecting Th2 mediated bronchial inflammation (miRNA-126, miRNA-21, miRNA-145, let7-mimic)
Time frame: 1 Year
Cange of eNO
Time frame: 1 Year
Change of leucocytes and neutrophile granulocytes
Time frame: 1 Year
FEV1-decrease in ECC
Time frame: 1 Year
Comparison eNO with significant dysregulated miRNA
Time frame: 1 Year
Comparison of change of leucocytes and neutrophile granulocytes with significant dysregulated miRNA
Time frame: 1 Year
Comparison of ACT with significant dysregulated miRNA
Time frame: 1 Year
Comparison of DI with significant dysregulated miRNA
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Background: PubMed 23634861Parsons JP, Hallstrand TS, Mastronarde JG, Kaminsky DA, Rundell KW, Hull JH, Storms WW, Weiler JM, Cheek FM, Wilson KC, Anderson SD; American Thoracic Society Subcommittee on Exercise-induced Bronchoconstriction. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction. Am J Respir Crit Care Med. 2013 May 1;187(9):1016-27. doi: 10.1164/rccm.201303-0437ST.
- Background: PubMed 31097027Dressler 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.
- Background: PubMed 29526567Dressler M, Salzmann-Manrique E, Zielen S, Schulze J. Exhaled NO as a predictor of exercise-induced asthma in cold air. Nitric Oxide. 2018 Jun 1;76:45-52. doi: 10.1016/j.niox.2018.03.004. Epub 2018 Mar 8.
- Background: PubMed 22326606Schulze J, Smith HJ, Fuchs J, Herrmann E, Dressler M, Rose MA, Zielen S. Methacholine challenge in young children as evaluated by spirometry and impulse oscillometry. Respir Med. 2012 May;106(5):627-34. doi: 10.1016/j.rmed.2012.01.007. Epub 2012 Feb 10.
- 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 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.
- Background: PubMed 22989372Schulze 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.
- Background: PubMed 19161635Anderson SD, Charlton B, Weiler JM, Nichols S, Spector SL, Pearlman DS; A305 Study Group. Comparison of mannitol and methacholine to predict exercise-induced bronchoconstriction and a clinical diagnosis of asthma. Respir Res. 2009 Jan 23;10(1):4. doi: 10.1186/1465-9921-10-4.
- Background: PubMed 22789953Driessen JM, van der Palen J, van Aalderen WM, de Jongh FH, Thio BJ. Inspiratory airflow limitation after exercise challenge in cold air in asthmatic children. Respir Med. 2012 Oct;106(10):1362-8. doi: 10.1016/j.rmed.2012.06.017. Epub 2012 Jul 11.
- Background: PubMed 22948442Zielen S, Lieb A, De La Motte S, Wagner F, de Monchy J, Fuhr R, Munzu C, Koehne-Voss S, Riviere GJ, Kaiser G, Erpenbeck VJ. Omalizumab protects against allergen- induced bronchoconstriction in allergic (immunoglobulin E-mediated) asthma. Int Arch Allergy Immunol. 2013;160(1):102-10. doi: 10.1159/000339243. Epub 2012 Aug 28.
- Background: PubMed 25748838Rosewich M, Zissler UM, Kheiri T, Voss S, Eickmeier O, Schulze J, Herrmann E, Ducker RP, Schubert R, Zielen S. Airway inflammation in children and adolescents with bronchiolitis obliterans. Cytokine. 2015 May;73(1):156-62. doi: 10.1016/j.cyto.2014.10.026. Epub 2015 Mar 6.
- Background: PubMed 32410855Jerkic SP, Michel F, Donath H, Herrmann E, Schubert R, Rosewich M, Zielen S. Calprotectin as a New Sensitive Marker of Neutrophilic Inflammation in Patients with Bronchiolitis Obliterans. Mediators Inflamm. 2020 May 1;2020:4641585. doi: 10.1155/2020/4641585. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Melanie Dreßler, MD 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?
A study testing Exercise challenge in the cold chamber (ECC), mRNA profile and standard diagnostic in people with Exercise Induced Asthma and House Dust Mite Allergy, 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 8 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 3 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melanie Dreßler, MD (+49-69-6301-4588, melanie.dressler@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysregulation of miRNA-146 (time frame: 1 Year). 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 NCT05174689, which also lists 27 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 3 Jan 2022.