An observational study in Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 1 site in United States. Open to participants aged 3 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
Background:
Allergic or sinus diseases can affect the skin, sinuses, airways, and other parts of the body. Examples include pollen and environmental allergies, food allergies, asthma, and eczema. To learn more about how to prevent and treat these diseases, researchers need to study data, blood, fluid, and tissue samples from people affected by them.
Objective:
To collect data, blood, fluid, and tissue samples from people with allergic or sinus diseases.
Eligibility:
People aged 3 to 100 years with allergic or sinus diseases.
Design:
Participants will have at least one clinic visit, and most participants will have a baseline visit, annual visit, and an end of study visit. The duration of the study is 1 to 3 years. During the first clinic visit, the following procedures will be done to collect data, blood, fluid, and tissue samples:
Participants may return for more visits for up to 3 years.
Study Description:
This is a single-site repository study that will prospectively collect samples and data from participants with allergic and atopic diseases and associated conditions such as chronic rhinosinusitis and nasal polyposis, through the evaluation, testing, and monitoring of patients with these conditions at the NIH Clinical Center (CC) and via telehealth visits and/or send-in samples. This repository will provide atopic participant samples for translational studies performed by NIH investigators or their collaborators and also serve as a means for recruiting atopic control patients to ongoing NIAID and National Institute on Deafness and Other Communication Disorders (NIDCD) clinical studies.
Participants aged 3 and older will present to the NIH CC for visits for clinical evaluation and treatment of allergic diseases as appropriate. Data and samples obtained but not utilized from clinically indicated procedures will be put into the repository (e.g. physical exams, nasal endoscopy, blood tests, olfaction assessment, and nasal sinus polyp biopsy where appropriate).
Samples that may be collected prospectively for inclusion in the repository include nasal brushings, nasal lining fluid, blood, urine, and skin swabs. Additionally, extra skin, nasal sinus polyp, and gastrointestinal biopsies may be collected during clinically indicated procedures. The following assessments will also be performed for research purposes: Data collected from patient reported outcomes (PROs) and questionnaires, blood, urine, allergy skin prick testing, skin swab, and pulmonary function testing to include fractional exhaled nitric oxide testing (FeNO). Data/samples from clinical procedures will also be collected for the repository, where possible.
Although standard of care treatment may be initiated and monitored under this protocol, it will be expected that after a set number of visits outlined in the manual of operations, continued medication prescribing and monitoring will be transitioned to the referring provider, the patient s outside primary physician or allergist-immunologist, or another NIH protocol depending on the patient condition and importance for biorepository collection. No experimental treatments will be offered under this protocol.
Objective:
To create a repository of clinical, laboratory, and diagnostic data and specimens from a cohort of suspected or confirmed atopic or allergic individuals with diverse disorders seen by allergist-immunologists and rhinologists.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 166 across 327 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants aged 3 and older with suspected or diagnosed allergic diseases of varying types will be enrolled. Participants will be generally healthy, community-dwelling participants without severe medical needs requiring hospitalization.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1)Aged 3 to 100 years.
2a) Suspected or confirmed allergic, atopic, respiratory, or nasal/sinus disorder or have suspected or confirmed history of an immune dysregulatory disorder, OR
2b) Have a clinical history of an immediate reaction to aeroallergens, food, insect stings, or medications.
3) Able to provide .
4) Have or are willing to obtain a non-NIH primary physician who will manage all health conditions and be responsive for emergency medical treatment, if required.
5) Willing to allow storage of blood, skin swabs, nasal fluid/brushings, bodily fluids, and other clinically appropriate tissue specimens or data generated during participation for future use in medical research.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this
study:
For additional skin only:
For additional nasal-sinus polyp biopsies only:
For skin prick testing
a. Participants who are pregnant.
Endoscopic Biopsy
Participants will be selected in an equitable manner from the available pool of potentially eligible individuals, without regard to factors such as sex, gender, race, ethnicity, sexual orientation, or socioeconomic status.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Conditions that may be initially evaluated or managed by an allergist-immunologist or rhinologist but not categorized in (1) or (2) above (eg, hypereosinophilia, mast cell disorders, pruritus, chronic cough, smell disorders)
Individuals with a suspected allergic or atopic disease, but without demonstrated allergen sensitization (eg, contact hypersensitivity, chronic spontaneous urticaria, drug allergy)
Individuals with an allergic, atopic, or sinus disease (eg, atopic dermatitis, eosinophilic esophagitis (EoE), asthma, chronic rhinosinusitis with polyposis) with documented allergen sensitization in the skin or blood
Create a repository of clinical, laboratory, and diagnostic data and specimens from a cohort of suspected or confirmed atopic or allergic individuals with diverse disorders seen by allergist-immunologists and rhinologists.
Time frame: 20 years
Plan to share: Yes — IPD and data dictionaries will be available to researchers who request data or sample use on this protocol. IPD related to an ensuing publication for e.g. IPD related to large datasets required to be deposited will be shared with appropriate annotation by the individual researchers as required by journals and/or NIH policy, whichever is more stringent.
Supporting information: Statistical analysis plan, Clinical study report
Time frame: As this is a biorepository it would be impossible to share all IPD in the entire study. IPD related to individual secondary use protocols will be required to be shared at the time of publication by individual investigators as well as the associated statistical analysis planned/performed. Clinical data associated with the particular study will be required to be deposited according to the DSMP
Access criteria: IPD data sharing will occur after request/approval by the PI (or designee) and in conjunction with the procedures/approvals outlined in the appendix of the protocol. Sharing will be open to other investigators in the LAD and the NIH, and with NIDCD investigators as outlined in the associated RCA.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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