Epigenetic Regulation of Excercise Induced Asthma
Exercise challenge in the cold chamber (ECC)
+ mRNA profile
+ standard diagnostic
Exercise-Induced Allergies+12
+ Dust Mite Allergy
+ Asthma
Diagnostic Study
Summary
Study start date: August 1, 2021
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.68 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 24 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Group II
Group III
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Universitätsklinikum Frankfurt
Frankfurt am Main, GermanyOpen Universitätsklinikum Frankfurt in Google Maps