Clinical trial NCT05334940: Atopy Network - Comprehensive Allergy Centers: Medical Care of Patients With Moderate to Severe Allergic Diseases
Official title: Atopy Network - Comprehensive Allergy Centers: Medical Care of Patients With Moderate to Severe Allergic Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Disorders
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a moderate to severe primary atopic disorder and at least one additional secondary underlying atopic disease

Brief summary: 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.

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

Primary outcomes:
measure: Comorbidity Food Allergy
timeFrame: 3 years
measure: Comorbidity Atopic Dermatitis
timeFrame: 3 years
measure: Comorbidity Bronchial Asthma
timeFrame: 3 years
measure: Comorbidity Chronic rhinosinusitis with nasal polyps
timeFrame: 3 years
measure: Comorbidity Chronic Spontaneous Urticaria
timeFrame: 3 years
measure: Comorbidity Eosinophilic Esophagitis
timeFrame: 3 years
measure: Comorbidity Allergic Rhinitis
timeFrame: 3 years
Secondary outcomes:
measure: Food Allergy Severity
timeFrame: 3 years
measure: Atopic Dermatitis Severity
timeFrame: 3 years
measure: Allergic Rhinitis Severity
timeFrame: 3 years
measure: Bronchial Asthma Severity FVC
timeFrame: 3 years
measure: Bronchial Asthma Severity FEV1
timeFrame: 3 years
measure: Bronchial Asthma Severity FEF25-75
timeFrame: 3 years
measure: Chronic Spontaneous Urticaria LQ (CUQ2oL)
timeFrame: 3 years
measure: Chronic Spontaneous Urticaria Severity (AECT)
timeFrame: 3 years
measure: Chronic Spontaneous Urticaria Severity (UAS7)
timeFrame: 3 years
measure: Eosinophilic Esophagitis Severity and/or LQ
timeFrame: 3 years
measure: Chronic Rhinosinusitis with Nasal Polyposis Severity
timeFrame: 3 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Margitta Worm, Prof.
role: STUDY_CHAIR
References: