Atopy Network - Comprehensive Allergy Centers: Medical Care of Patients With Moderate to Severe Allergic Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Comorbidity Food Allergy
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Comorbidity Food Allergy
Time Frame: 3 years
Improvement of at least one comorbidity with biologics therapy using a standardized questionnaire to assess disease severity for the following atopic diseases: Food Allergy: Food Allergy Quality of Life Questionnaire (FAQLQ) (type-dependent 23-30 items, score between 0 and 6; mean of scores, minimum = 0, maximum = 6; higher score = higher impact on quality of life)
Comorbidity Atopic Dermatitis
Time Frame: 3 years
Improvement of at least one comorbidity with biologics therapy using a standardized questionnaire to assess disease severity for the following atopic diseases: Atopic Dermatitis: Atopic Dermatitis-Control-Test (ADCT) (6 items, score between 0 and 4; sum, minimum = 0, maximum = 24; higher score = higher severity)
Comorbidity Bronchial Asthma
Time Frame: 3 years
Improvement of at least one comorbidity with biologics therapy using a standardized questionnaire to assess disease severity for the following atopic diseases: Bronchial Asthma: Asthma-Control-Test (ACT) (5 items, score between 0 and 5; sum, minimum = 0, maximum = 25; higher score = better disease control)
Comorbidity Chronic rhinosinusitis with nasal polyps
Time Frame: 3 years
Improvement of at least one comorbidity with biologics therapy using a standardized questionnaire to assess disease severity for the following atopic diseases: Chronic rhinosinusitis with nasal polyps: 22 Items Sino-Nasal Outcome Test (SNOT22) (22 items, score between 0 and 5; sum, minimum = 0, maximum = 110; higher score = higher impact on quality of life)
Comorbidity Chronic Spontaneous Urticaria
Time Frame: 3 years
Improvement of at least one comorbidity with biologics therapy using a standardized questionnaire to assess disease severity for the following atopic diseases: Chronic Spointaneous Urticaria: Urticaria Control Test (UCT) (4 items, score between 0 and 5; sum, minimum = 0, maximum = 20; higher score = better control)
Comorbidity Eosinophilic Esophagitis
Time Frame: 3 years
Improvement of at least one comorbidity with biologics therapy using a standardized questionnaire to assess disease severity for the following atopic diseases: Eosinophilic Esophagitis: Dysphagia Symptoms Questionnaire (DSQ) (4 items, score between 0 and 4 but question-dependent; sum, minimum = 0, maximum = 10; higher score = higher impact)
Comorbidity Allergic Rhinitis
Time Frame: 3 years
Improvement of at least one comorbidity with biologics therapy using a standardized questionnaire to assess disease severity for the following atopic diseases: Allergic Rhinitis: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) (28 items, score between 0 and 6; mean, minimum = 0, maximum = 6; higher score = higher impact on quality of life)
Secondary Outcomes
- Food Allergy Severity(3 years)
- Atopic Dermatitis Severity(3 years)
- Allergic Rhinitis Severity(3 years)
- Bronchial Asthma Severity FVC(3 years)
- Bronchial Asthma Severity FEV1(3 years)
- Bronchial Asthma Severity FEF25-75(3 years)
- Chronic Spontaneous Urticaria LQ (CUQ2oL)(3 years)
- Chronic Spontaneous Urticaria Severity (AECT)(3 years)
- Chronic Spontaneous Urticaria Severity (UAS7)(3 years)
- Eosinophilic Esophagitis Severity and/or LQ(3 years)
- Chronic Rhinosinusitis with Nasal Polyposis Severity(3 years)
Investigators
Margitta Worm
Prof. Dr. med.
Charite University, Berlin, Germany