Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug aNCT06732414
A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up
An observational study of Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 100 years
- Conditions the study is for
- Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2025to 1 Nov 2045
- Phase
- Observational
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 3 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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 hypersensitivity reaction to aeroallergens, food, insect stings, or medications.
- 3) Able to provide informed consent.
- 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.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this
- study:
- Any condition(s) or diagnosis, physical and/or psychological, that the investigator feels precludes the patient from participation in the study.
- For additional skin biopsies only:
- Individuals who have a history of keloid formation
- Children (<18 years old)
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- Participants who are pregnant
- For additional nasal-sinus polyp biopsies only:
- Individuals on blood thinners unless they have already been stopped for the procedure
- Children (<18 years old)
- Participants who are pregnant
- For skin prick testing
- Participants who are pregnant.
- Endoscopic Biopsy
- Uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist's Physical Status Classification System (https://www.asahq.org/standards-and-practice-parameters/statement-on-asaphysical-status-classification-system)
- History of adverse reaction to conscious sedation or general anesthesia required for endoscopy
- Hemoglobin < 11 g/dL
- Platelet count < 100,000 microL
- Pregnant or breastfeeding
- Severe hypoxemia due to chronic pulmonary disease
- Recent abdominal surgery
- Anticoagulant therapy that cannot be interrupted
- Younger than 18 years of age
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
Hye Jeong Bolan, M.S.N., (301) 594-1233, bolanhy@mail.nih.gov
About this study
Official title: A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-up
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.
Read more
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:
- Blood will be collected.
- Cells and fluid may be collected from the inside of the nose using a long swab, and a small piece of skin may be scraped from inside the nose.
- Skin cells will be collected by rubbing with a cotton swab.
- A urine sample will be collected.
- Allergy skin prick tests. Allergy-causing substances will be placed on the back or arm and the skin underneath gently scratched. If the participant is allergic to the substance, the skin may become red, itchy, and swollen locally ( at the site of the test).
- Lung function test. Participants will breathe into a machine that measures the air moving in and out of their lungs.
- If, as part of their routine care, participants are undergoing procedures such as having nasal polyps removed, skin tissue samples taken, or gastrointestinal biopsies, additional tissues may be collected for this study.
- Participants will complete online questionnaires regarding their symptoms, health, and life.
Participants may return for more visits for up to 3 years.
Read the detailed description
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.
- Conditions
- Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a
- Keywords
- Allergy, repository, data, sample collection
- Medical subject headings
- Hypersensitivity, Asthma, Rhinitis, Allergic, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conditions that may be initially evaluated or managed by A&I but not categorized in 1 or 2 above | 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 | 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 | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start28 Jan 2025
- Primary completion1 Nov 2044 (estimated)
- Study completion1 Nov 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug aStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Paneez Khoury, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732414
- Sponsor's protocol ID
- 10001928
- Other IDs
- 001928-I
- Status last verified
- 13 Oct 2026
- First submitted
- 12 Dec 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.