J45
Conditions
Interventions
Group 1: Arm 1 Children with Asthma:
- after 0 and 24 months: Recruitment Informed consent Baseline Questionnaire, PFR, NO, Spirometry, blood sample, NPSwap, Training for cards, Free-Running Test, Sk
Sponsors
Universitätsklinikum Erlangen
Anästhesie / Molekulare Pneumologie
Eligibility
Sex/Gender
All
Age
4 Years to 6 Years
Inclusion criteria
Inclusion criteria: - Mild to moderate persistent severity according to updated International Guidelines - Written informed consent from the child’s parents/guardian’s - Gestational age 36 weeks or above - A diagnosis of asthma within the last 2 years, confirmed by a doctor of the participating study centre - 3 episodes in the preceding 12 month (1 in the last 6 months) - The child is able to perform at least a Peak Expiratory Flow (PEF) maneuver - The legal custodian has the verbal, writing and mental ability to understand the intent and character of the study - Age 4-6 years (beginning at the day of the 4th birthday and ending at the day of the 6th birthday)
Exclusion criteria
Exclusion criteria: - Severe/brittle asthma - Children receiving immunotherapy - More than 6 courses of oral steroids during the proceeding 12 months - Other chronic respiratory diseases (CF, BPD, immunodeficiencies) except allergic rhinits - other chronical diseases or permanent medical treatment except for allergic exzema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 0 and 24 month Genexpression with Real-Time PCR and ELISA from blood-PBMC (Peripheral Blood Mononuclear Cell) | — |
Secondary
| Measure | Time frame |
|---|---|
| By each hospital visit Fractionated Exhaled NO (FeNO-Monitor) Measurement and daily FEV1 measurement by electronic spirometer, Microbiology Nasal Swabs (Collaboration Prof. Dr. Bogdan) | — |
Countries
Belgium, Finland, Germany, Greece, Poland
Contacts
Public ContactSusetta Finotto
Universitätsklinikum Erlangen Anästhesie Abteilung Molekulare Pneumologie
Outcome results
None listed