Back to resultsEpigenetic Regulation of Exercise Induced Asthma
Primary Purpose
Exercise Induced Asthma, House Dust Mite Allergy
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise challenge in the cold chamber (ECC)
mRNA profile
standard diagnostic
Sponsored by
About this trial
This is an interventional diagnostic trial for Exercise Induced Asthma focused on measuring Exercise Induced Asthma, eNO, exercise challenge, micro RNAs
Eligibility Criteria
For EIA patients
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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
- 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
Inclusion Criteria:
- written agreement
- age >=18 and <= 24
Exclusion Criteria:
- 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
Sites / Locations
- Universitätsklinikum FrankfurtRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
EIA wih house dust mite
EIA without sensitization
Healthy controls
Arm Description
Patients with EIA and house-dust mite allergy and an eNO > 30 ppb
Patients with EIA without allergic sensitization and an eNO < 20 ppb
Healthy controls without allergic sensitization or known asthma
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Cange of eNO
Change of eNO after ECC in the EIA subgroups compared to the healthy controls
Change of leucocytes and neutrophile granulocytes
Change of leucocytes and neutrophile granulocytes after ECC in the EIA subgroups compared to the healthy controls
FEV1-decrease in ECC
Comparison of the FEV1-decrease in ECC with significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
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
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
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
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
Full Information
NCT ID
NCT05174689
First Posted
August 30, 2021
Last Updated
December 14, 2021
Sponsor
Johann Wolfgang Goethe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05174689
Brief Title
Epigenetic Regulation of Exercise Induced Asthma
Official Title
Epigenetic Regulation of Excercise Induced Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Induced Asthma, House Dust Mite Allergy
Keywords
Exercise Induced Asthma, eNO, exercise challenge, micro RNAs
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EIA wih house dust mite
Arm Type
Other
Arm Description
Patients with EIA and house-dust mite allergy and an eNO > 30 ppb
Arm Title
EIA without sensitization
Arm Type
Other
Arm Description
Patients with EIA without allergic sensitization and an eNO < 20 ppb
Arm Title
Healthy controls
Arm Type
Other
Arm Description
Healthy controls without allergic sensitization or known asthma
Intervention Type
Diagnostic Test
Intervention Name(s)
Exercise challenge in the cold chamber (ECC)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
mRNA profile
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
standard diagnostic
Intervention Description
bodyplethysmography, spirometry, exhaled NO, skin prick test, asthma control test (ACT)
Primary Outcome Measure Information:
Title
Dysregulation of miRNA-146
Description
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.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Dysregulation miRNAs affecting Th2 mediated bronchial inflammation (miRNA-126, miRNA-21, miRNA-145, let7-mimic)
Description
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.
Time Frame
1 Year
Title
Cange of eNO
Description
Change of eNO after ECC in the EIA subgroups compared to the healthy controls
Time Frame
1 Year
Title
Change of leucocytes and neutrophile granulocytes
Description
Change of leucocytes and neutrophile granulocytes after ECC in the EIA subgroups compared to the healthy controls
Time Frame
1 Year
Title
FEV1-decrease in ECC
Description
Comparison of the FEV1-decrease in ECC with significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Time Frame
1 Year
Title
Comparison eNO with significant dysregulated miRNA
Description
Comparison of the initial value of exhaled NO with significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Time Frame
1 Year
Title
Comparison of change of leucocytes and neutrophile granulocytes with significant dysregulated miRNA
Description
Comparison of the increase of leucocytes and neutrophile granulocytes after ECC significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Time Frame
1 Year
Title
Comparison of ACT with significant dysregulated miRNA
Description
Comparison of the score in ACT with significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Time Frame
1 Year
Title
Comparison of DI with significant dysregulated miRNA
Description
Comparison of the scoresin DI with significant dysregulated miRNA in the EIA subgroups compared to the healthy controls
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For EIA patients
Inclusion Criteria:
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%
Exclusion Criteria:
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
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
Inclusion Criteria:
written agreement
age >=18 and <= 24
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Dreßler, MD
Phone
+49-69-6301-4588
Email
melanie.dressler@kgu.de
First Name & Middle Initial & Last Name or Official Title & Degree
Helena Donath, MD
Phone
+49-69-6301-4588
Email
helena.donath@kgu.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Dreßler, MD
Organizational Affiliation
Johann Wolfgang Goethe University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Dreßler, MD
Phone
+49-69-6301-4588
Email
melanie.dressler@kgu.de
First Name & Middle Initial & Last Name & Degree
Helena Donath, MD
Phone
+49-69-6301-4588
Email
helena.donath@kgu.de
12. IPD Sharing Statement
Plan to Share IPD
No
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Epigenetic Regulation of Exercise Induced Asthma
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