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Description of mechanistic processes and detection of novel biomarkers during exacerbation in children and adolescents with bronchial asthma and chronic bronchitis/Wheeze.

Description of mechanistic processes and detection of novel biomarkers during exacerbation in children and adolescents with bronchial asthma and chronic bronchitis/Wheeze.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015738
Enrollment
300
Registered
2018-10-31
Start date
2017-12-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J45.0 J45.1 J45.8 J45.9 J20.9 J40 J42 J20 J44 J41.0 J41.1 J41.8

Interventions

Group 1: For this study, children and adolescents with bronchial asthma and wheeze/chronic bronchitis will be recruited. Study centers are the Center for Pediatric and Adolescent Medicine of the Helio

Sponsors

Zentrum für Kinder- und Jugendmedizin, Zentrum für Forschung in der Klinischen Medizin, Helios Universitätsklinikum Wuppertal, Universität Witten/Herdecke
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Months to 65 Years

Inclusion criteria

Inclusion criteria: The following inclusion criteria apply to the asthma cohort: Study patients with previously diagnosed bronchial asthma who are between = 5-6 and < 18 years of age can be included. In addition, study patients with a previously undiagnosed bronchial asthma but with a history of asthma typical symptoms and with current respiratory symptoms (in the sense of an initial diagnosis) can also be included. The diagnosis of bronchial asthma is based on national and international guidelines (GINA, ISAAC, NVL). See also the exact diagnostic criteria for bronchial asthma in the literature. In addition, there must be no preterm birth and a partus = 37. SSW must have taken place. Other underlying diseases as well as postnatal respiratory adaptation disorders are considered as exclusion criteria. The inclusion criteria of the Wheezer cohort are as follows. Subjects with recurrent obstructive bronchitis episodes between the = 3. months to = 5./6. year of life with at least 2 obstructive bronchitis episodes, at least one outpatient and one inpatient treatment (the current inpatient presentation can also be considered as one disease episode) fulfill the inclusion criteria. Since this cohort description and the diagnosis in the literature are quite heterogeneous, we have decided on this number of disease episodes. Furthermore, the same exclusion criteria apply as for the asthma cohort. For the so-called healthy cohort, the following inclusion criteria apply: healthy children and adolescents between the age of = 3 months and < 65 years with no underlying chronic disease, no postnatal adaptation included, no mechanical respiratory support, and no developmental delay, no long-term medication, and no febrile infection in the last 3 weeks.

Exclusion criteria

Exclusion criteria: See also inclusion criteria, furthermore missing inclusion criteria and Lack of consent of the patient or guardian.

Design outcomes

Primary

MeasureTime frame
Clinical course 3 month after exacerbation; comparison of experimental parameters/results between acute exacerbation and clinically healthy condition

Countries

Germany

Contacts

Public ContactSören;Malik Lutz;Aydin

Kinder- und Jugendmedizin, Kinderneurologie Helios Klinikum Niederberg – Akademisches Lehrkrankenhaus der Universität Duisburg/Essen;Zentrum für Kinder- und JugendmedizinHelios Universitätsklinikum WuppertalUniversität Witten/Herdecke

soeren.lutz@helios-gesundheit.de;malik.aydin@helios-gesundheit.de02051 9820;00492028962384

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026