NCT05174689

Epigenetic Regulation of Exercise Induced Asthma

Epigenetic Regulation of Excercise Induced Asthma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 24 Years
• Healthy volunteers: Accepted

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.

Conditions

• Exercise Induced Asthma
• House Dust Mite Allergy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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	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.
DIAGNOSTIC_TEST	standard diagnostic	bodyplethysmography, spirometry, exhaled NO, skin prick test, asthma control test (ACT)

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-08-01
• Completion: 2022-09-01
• First posted: 2022-01-03
• Last updated: 2022-01-03

Locations

1 site across 1 country: Germany