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

NCT05334940 | Recruiting

• 1 other identifier: Atopy Registry
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Disorders

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (11)

• 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

Study Arms (1)

Atopic disorders

Patients with at least 2 atopic disorders who are eligible for systemic therapy with biologics

Other: not applicable, observational study

Interventions

not applicable, observational study OTHER

Patients do not receive intervention

Atopic disorders

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \<2 atopic disorders
• poor compliance
• pregnancy or breastfeeding

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

optional blood sampling, stool sampling

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Margitta Worm, Prof.

  Charite University, Berlin, Germany

  STUDY CHAIR

Central Study Contacts

Margitta Worm, Prof.

CONTACT

+49 30 450 518105; margitta.worm@charite.de

Philipp Globig, Dr.

CONTACT

+49 30 450 518409; philipp.globig@charite.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 19, 2022
• Study Start: December 8, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

DE (1)