Recruiting

Observational Study

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT06732414

Conditions

Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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. 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:

  • 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.

Conditions

Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a

Study ID

NCT06732414

Start date

Jan 28, 2025

Status verified date

Jul 15, 2026

Completion date

Nov 1, 2045

Anticipated

Primary completion date

Nov 1, 2044

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this

study:

1. Any condition(s) or diagnosis, physical and/or psychological, that the investigator feels precludes the patient from participation in the study.
2. For additional skin biopsies only:

1. Individuals who have a history of keloid formation
2. Children (<18 years old)
3. Participants who are pregnant
3. For additional nasal-sinus polyp biopsies only:

1. Individuals on blood thinners unless they have already been stopped for the procedure
2. Children (<18 years old)
3. Participants who are pregnant
4. For skin prick testing

a. Participants who are pregnant.
5. Endoscopic Biopsy

1. 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)
2. History of adverse reaction to conscious sedation or general anesthesia required for endoscopy
3. Hemoglobin < 11 g/dL
4. Platelet count < 100,000 microL
5. Pregnant or breastfeeding
6. Severe hypoxemia due to chronic pulmonary disease
7. Recent abdominal surgery
8. Anticoagulant therapy that cannot be interrupted
9. 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.

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Conditions that may be initially evaluated or managed by A&amp;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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Jul 17, 2026

Last verified

Jul 15, 2026

Keywords

  • Allergy, repository, data, sample collection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-07-17.