Epigenetic Regulation of Exercise Induced Asthma

Johann Wolfgang Goethe University Hospital

Status: Unknown

Conditions: House Dust Mite Allergy; Exercise Induced Asthma

Treatments: Diagnostic Test: Exercise challenge in the cold chamber (ECC); Diagnostic Test: mRNA profile; Diagnostic Test: standard diagnostic

Study type: Interventional

Funder types: Other

Identifiers

NCT05174689

E68/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 12 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 3 patient groups

EIA wih house dust mite

Other group

Description:

Patients with EIA and house-dust mite allergy and an eNO \> 30 ppb

Treatment:

Diagnostic Test: Exercise challenge in the cold chamber (ECC)

Diagnostic Test: mRNA profile

Diagnostic Test: standard diagnostic

EIA without sensitization

Other group

Description:

Patients with EIA without allergic sensitization and an eNO \< 20 ppb

Treatment:

Diagnostic Test: Exercise challenge in the cold chamber (ECC)

Diagnostic Test: mRNA profile

Diagnostic Test: standard diagnostic

Healthy controls

Other group

Description:

Healthy controls without allergic sensitization or known asthma

Treatment:

Diagnostic Test: mRNA profile

Diagnostic Test: standard diagnostic