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

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Disorders
• Intervention / Treatment: Other: not applicable, observational study

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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Margitta Worm, Prof.; Phone Number: +49 30 450 518105; Email: margitta.worm@charite.de
• Study Contact Backup: Name: Philipp Globig, Dr.; Phone Number: +49 30 450 518409; Email: philipp.globig@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité - Universitätsmedizin Berlin
    • Contact: Margitta Worm, Prof.; Phone Number: +49 30 450 518105; Email: margitta.worm@charite.de
    • Contact: Philipp Globig, Dr.; Phone Number: +49 30 450 518409; Email: philipp.globig@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atopic disorders; Patients with at least 2 atopic disorders who are eligible for systemic therapy with biologics	Other: not applicable, observational study; Patients do not receive intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Allergy Severity	Altered assessment of severity by investigation of oral thresholds and accidental reactions by oral food challenge.	3 years
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
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
Bronchial Asthma Severity FVC	Altered assessment of severity using the lung function parameter Forced Vital Capacity (FVC)	3 years
Bronchial Asthma Severity FEV1	Altered assessment of severity using the lung function parameter Forced Expiratory Volume in 1 second (FEV1)	3 years
Bronchial Asthma Severity FEF25-75	Altered assessment of severity using the lung function parameter Forced expiratory flow 25-75 (FEF25-75).	3 years
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Chair: Margitta Worm, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: Atopy Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No