Atopy Network - Comprehensive Allergy Centers: Medical Care of Patients With Moderate to Severe Allergic Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: not applicable, observational study.
- Who it may be relevant to
- Registry conditions: Atopic Disorders. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The Atopy Registry aims to assess data about atopic disorders and their medical care in a standardized form. With this, the comparative efficacy, tolerability and safety of systemic therapies for atopic disorders should be investigated. An optional additional module "Bioanalytic" shall provide insights into further connections regarding immunology, genetics and microbiome.
Detailed description
The prevalence of atopic disorders increased in the western countries within the past decades. Atopic disorders are among others: food allergy, atopic dermatitis, allergic rhinitis, bronchial asthma, chronic spontaneous urticaria, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyposis.
Seriously affected patients often have coexisting atopic disorders. In fact, 60-75% of the patients with a severe atopic dermatitis also suffer from an allergic rhinoconjunctivitis and 40-50% from bronchial asthma. This leads to a decreased quality of life (LG) especially in seriously affected patients.
The treatment of atopic disorders is not standardized yet. The Atopy Registry should promote the creation of a Germany-wide registry for different atopic disorders.Furthermore, the registry should characterize the medical care of patients with atopic disorders (patient satisfaction, therapy order, treatment success). This study serves as a longterm observation und is designed to compare different systemic therapies, since head-to-head studies regarding the efficacy are still missing. The analysis of biomaterial is involved to state possible correlations between endotype and phenotype.
Interventions
- Other not applicable, observational study
Patients do not receive intervention
Primary outcome measures
- Comorbidity Food Allergy [Time frame: 3 years]
- Comorbidity Atopic Dermatitis [Time frame: 3 years]
- Comorbidity Bronchial Asthma [Time frame: 3 years]
- Comorbidity Chronic rhinosinusitis with nasal polyps [Time frame: 3 years]
- Comorbidity Chronic Spontaneous Urticaria [Time frame: 3 years]
- Comorbidity Eosinophilic Esophagitis [Time frame: 3 years]
- Comorbidity Allergic Rhinitis [Time frame: 3 years]
Secondary outcome measures (11)
- Food Allergy Severity [Time frame: 3 years]
- Atopic Dermatitis Severity [Time frame: 3 years]
- Allergic Rhinitis Severity [Time frame: 3 years]
- Bronchial Asthma Severity FVC [Time frame: 3 years]
- Bronchial Asthma Severity FEV1 [Time frame: 3 years]
- Bronchial Asthma Severity FEF25-75 [Time frame: 3 years]
- Chronic Spontaneous Urticaria LQ (CUQ2oL) [Time frame: 3 years]
- Chronic Spontaneous Urticaria Severity (AECT) [Time frame: 3 years]
- Chronic Spontaneous Urticaria Severity (UAS7) [Time frame: 3 years]
- Eosinophilic Esophagitis Severity and/or LQ [Time frame: 3 years]
- Chronic Rhinosinusitis with Nasal Polyposis Severity [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- patients are at least 6 years old
- patients with a proven moderate to severe atopic disorder who are planned to receive a biologic systemic therapy
- at least one additional proven atopic disorder
Exclusion criteria
- <2 atopic disorders
- poor compliance
- pregnancy or breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
Germany · 1 center
- Charité - Universitätsmedizin Berlin — Berlin
Identifiers
NCT: NCT05334940 · Atopy Registry