Atopic DisordersATACNCT05334940
Atopy Network - Comprehensive Allergy Centers: Medical Care of Patients With Moderate to Severe Allergic Diseases
An observational study of Atopic Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Atopic Disorders
- What is being tested?
- not applicable, observational study
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 8 Dec 2022to 31 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Child, Adult, Older adult
Study population: Subjects with a moderate to severe primary atopic disorder and at least one additional secondary underlying atopic disease
Who may be able to join
- 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
Who cannot join
- <2 atopic disorders
- poor compliance
- pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117
Margitta Worm, Prof., +49 30 450 518105, margitta.worm@charite.de
Philipp Globig, Dr., +49 30 450 518409, philipp.globig@charite.de
About this study
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.
Read the 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.
- Conditions
- Atopic Disorders
- Being tested
- not applicable, observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not applicable, observational studyOther
Patients do not receive intervention
| Study group | Role | What they receive |
|---|---|---|
| Atopic disorders | Patients with at least 2 atopic disorders who are eligible for systemic therapy with biologics Receives: Other: not applicable, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3 years
Secondary outcomes (11)
Food Allergy Severity
Altered assessment of severity by investigation of oral thresholds and accidental reactions by oral food challenge.
Measured: 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)
Measured: 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)
Measured: 3 years
Bronchial Asthma Severity FVC
Altered assessment of severity using the lung function parameter Forced Vital Capacity (FVC)
Measured: 3 years
Bronchial Asthma Severity FEV1
Altered assessment of severity using the lung function parameter Forced Expiratory Volume in 1 second (FEV1)
Measured: 3 years
Bronchial Asthma Severity FEF25-75
Altered assessment of severity using the lung function parameter Forced expiratory flow 25-75 (FEF25-75).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start8 Dec 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DisordersStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margitta Worm, Charite University, Berlin, Germany
- Investigators
- Margitta Worm, Prof., Study chair, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334940
- Sponsor's protocol ID
- Atopy Registry
- Acronym
- ATAC
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2022
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atopy Network - Comprehensive Allergy Centers: Medical Care of Patients With Moderate to Severe Allergic Diseases
- ClinicalTrials.gov ID
- NCT05334940
- Acronym / sponsor ID
- ATAC / Atopy Registry
- Conditions
- Atopic Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atopic disorders | – | Other: not applicable, observational studyPatients with at least 2 atopic disorders who are eligible for systemic therapy with biologics |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with a moderate to severe primary atopic disorder and at least one additional secondary underlying atopic disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- <2 atopic disorders
- poor compliance
- pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| not applicable, observational studyPatients do not receive intervention | Other | Atopic disorders |
Primary outcome
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)
11 secondary outcomes
Food Allergy Severity
Time frame: 3 years
Atopic Dermatitis Severity
Time frame: 3 years
Allergic Rhinitis Severity
Time frame: 3 years
Bronchial Asthma Severity FVC
Time frame: 3 years
Bronchial Asthma Severity FEV1
Time frame: 3 years
Bronchial Asthma Severity FEF25-75
Time frame: 3 years
Chronic Spontaneous Urticaria LQ (CUQ2oL)
Time frame: 3 years
Chronic Spontaneous Urticaria Severity (AECT)
Time frame: 3 years
Chronic Spontaneous Urticaria Severity (UAS7)
Time frame: 3 years
Eosinophilic Esophagitis Severity and/or LQ
Time frame: 3 years
Chronic Rhinosinusitis with Nasal Polyposis Severity
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margitta Worm, Prof. study chair
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margitta Worm, Prof. (+49 30 450 518105, margitta.worm@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comorbidity Food Allergy (time frame: 3 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.