Atopy Network - Comprehensive Allergy Centers: Medical Care of Patients With Moderate to Severe Allergic Diseases

Atopic Disorders Clinical Trial

— ATAC  

Official title:

Atopy Network - Comprehensive Allergy Centers: Medical Care of Patients With Moderate to Severe Allergic Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05334940
• Other study ID #: Atopy Registry
• Status: Recruiting
• Start date: December 8, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2023
• Source: Charite University, Berlin, Germany
• Contact: Margitta Worm, Prof.
• Phone: +49 30 450 518105
• Email: margitta.worm[@]charite.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Disorders
• Hypersensitivity

Intervention

Other:
• not applicable, observational study
Patients do not receive intervention

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comorbidity Food Allergy	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)	3 years
Primary	Comorbidity Atopic Dermatitis	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)	3 years
Primary	Comorbidity Bronchial Asthma	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)	3 years
Primary	Comorbidity Chronic rhinosinusitis with nasal polyps	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)	3 years
Primary	Comorbidity Chronic Spontaneous Urticaria	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)	3 years
Primary	Comorbidity Eosinophilic Esophagitis	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)	3 years
Primary	Comorbidity Allergic Rhinitis	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)	3 years
Secondary	Food Allergy Severity	Altered assessment of severity by investigation of oral thresholds and accidental reactions by oral food challenge.	3 years
Secondary	Atopic Dermatitis Severity	Altered assessment of severity and/or LQ using the Eczema Area and Severity Index (EASI).; (Eczema Area and Severity; minimum = 0, maximum = 72; higher numbers = higher severity)	3 years
Secondary	Allergic Rhinitis Severity	Altered assessment of severity using the Total Nasal Symptom Score (TNSS). (Total Nasal Symptom Score; 3 items, score between 0 and 3; minimum = 0, maximum = 9; higher score = higher severity)	3 years
Secondary	Bronchial Asthma Severity FVC	Altered assessment of severity using the lung function parameter Forced Vital Capacity (FVC)	3 years
Secondary	Bronchial Asthma Severity FEV1	Altered assessment of severity using the lung function parameter Forced Expiratory Volume in 1 second (FEV1)	3 years
Secondary	Bronchial Asthma Severity FEF25-75	Altered assessment of severity using the lung function parameter Forced expiratory flow 25-75 (FEF25-75).	3 years
Secondary	Chronic Spontaneous Urticaria LQ (CUQ2oL)	Altered assessment of LQ using the Chronic Urticaria Questionnaire for Quality of Life (CUQ2oL).; (Chronic Urticaria Questionnaire for Quality of Life; 23 items, score between 0 and 4; the score is calculated in percentage, minimum = 0%, maximum = 100%; higher percentage = lower quality of life)	3 years
Secondary	Chronic Spontaneous Urticaria Severity (AECT)	Altered assessment of severity using the Angioedema Control Test (AECT). (Angioedema Control Test; 4 items, score between 0 and 4; minimum = 0, maximum = 16; lower score = higher severity)	3 years
Secondary	Chronic Spontaneous Urticaria Severity (UAS7)	Altered assessment of severity and/or LQ using the 7-Days Urticaria Activity Score (UAS7).; (7-Days Urticaria Activity Score; 2 items on 7 days, score between 0 and 3; minimum = 0, maximum = 42; higher score = higher severity)	3 years
Secondary	Eosinophilic Esophagitis Severity and/or LQ	Altered assessment of LQ using the Pediatric Quality of Life Inventory Eosinophilic Esophagitis (PedsQLEoE).; (Pediatric Quality of Life Inventory Eosinophilic Esophagitis; 33 items, score between 0 and 4; scores are graded on an 0-100 scale in opposite order (0=100, 1=75, 2=50, 3=25, 4=0); minimum = 0, maximum = 100; higher mean score = higher quality of life	3 years
Secondary	Chronic Rhinosinusitis with Nasal Polyposis Severity	Altered assessment of severity using the Nasal Polyp Score. (Nasal Polyp Score; 2 items, score between 0 and 4; minimum = 0, maximum = 8; higher score = higher severity)	3 years