Actively Recruiting

Age: 6Months - 18Years
All Genders
Healthy Volunteers
ID02496468

The All Age Asthma Cohort (ALLIANCE) of the German Center for Lung Research (DZL), Pediatric Arm

Led by LMU Klinikum · Updated on 2024-08-28

1500

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

Sponsors

L

LMU Klinikum

Lead Sponsor

G

German Federal Ministry of Education and Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating asthma and wheeze in children and how different forms and progressions of these conditions develop. The study aims to understand the underlying mechanisms and identify specific molecular patterns linked to various asthma and wheeze types. This may help create personalized treatments and early prevention methods. The research is part of the German Centre for Lung Research (DZL) and focuses on childhood asthma, including those who are newly diagnosed or already receiving controller therapy, as well as healthy children for comparison. Children with new or existing wheeze or asthma, including those not yet treated with steroids or leukotriene receptor antagonists, are being recruited. Healthy children matched by age and sex are also included as controls. Participants undergo regular assessments, including lung function tests and collection of biological samples such as blood, nasal secretions, and sputum. These procedures are repeated over time to monitor disease progression and molecular changes. The study uses standardized methods and quality controls across multiple sites. Participants will have detailed clinical exams, questionnaires, lung function tests, and provide various biological samples at baseline and during yearly follow-ups for up to two years. Researchers will track asthma prevalence, wheeze episodes, lung function, biomarkers like exhaled nitric oxide, and frequency of flare-ups. Data management and laboratory teams analyze the collected information using advanced computational techniques to identify patterns and potential targets for personalized care. The study aims to minimize missing data and apply statistical methods to ensure robust findings over the study duration.

CONDITIONS

Brief Title

Pediatric Arm of DZL All Age Asthma Cohort

Who Can Participate

Age: 6Months - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Informed consent by parents (and by children if age > 8 years)
  • Age between 6 months and 18 years
  • Term delivery (37 weeks or more)
  • Active or passive understanding of German
  • For ages 6 months to under 6 years: more than two wheeze episodes during the 12 months prior to inclusion
  • For ages 6 years and older: doctor diagnosed asthma according to current guidelines
Not Eligible

You will not qualify if you...

  • Known inborn or perinatal pulmonary disease
  • Airway malformation
  • Oxygen therapy after birth lasting more than 24 hours
  • Ventilator support or mechanical ventilation after birth
  • Diagnoses of cystic fibrosis or primary ciliary dyskinesia
  • Heart failure diagnosed after birth affecting pulmonary circulation
  • Major respiratory diseases such as interstitial lung disease
  • Any current non-atopic comorbidity
  • Fever of at least 38.5�B0C during the last two weeks prior to the planned first visit

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo comprehensive clinical assessment including questionnaires, physical examination, lung function tests, and collection of biomaterials to establish asthma or wheeze phenotypes.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Up to 2 years

Participants with new-onset or controller therapy wheeze/asthma are followed-up regularly to assess asthma trajectories, exacerbations, and biomarker changes using the same clinical tools and biomaterial collections as at baseline. Healthy controls do not undergo follow-up.

Yearly visits for up to 2 years

Trial Site Locations

Total: 5 locations

1

University Children's Hospital Cologne, Department of Paediatric Allergology and Pneumology

Cologne, Germany, 50937

Actively Recruiting

2

Medizinische Hochschule Hannover, Biomedical Research in Endstage and Obstructive Lung Disease

Hanover, Germany, 30625

Actively Recruiting

3

Universitaetsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin, Airway Research Center North

Lübeck, Germany, 23528

Actively Recruiting

4

Klinik für Kinder- und Jugendmedizin, Universitaetsklinikum Giessen und Marburg GmbH, Universities of Giessen and Marburg Lung Center

Marburg, Germany, 35033

Actively Recruiting

5

Klinikum der Universitaet Muenchen, Comprehensive Pulmonary Center Munich

Munich, Germany, 80337

Actively Recruiting

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Research Team

E

Esther Zeitlmann, Diplom

B

Bianca Schaub, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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