UnknownPhase 1

Airway Immune Response to Allergens (Use Lay Language Here)

United States12 participantsStarted 2021-10-28

Plain-language summary

Most asthma is allergic in origin. The purpose of this study is to better understand the airway immune response to inhaled allergens in order to identify factors that promote asthma.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant must be able to understand and provide informed consent.
✓. Age between 18 and 50 years.
✓. Clinical history of at least one of the following reactions to cat dander or dust mite:
✓. Allergic rhinitis, with one or more of nasal congestion, sneezing, runny nose or post- nasal drainage,
✓. Allergic conjunctivitis, with one or more of ocular itching, tearing or swelling, or
✓. Urticarial reactions to contact with cats.
✓. Positive allergen prick test to the allergen causing clinical symptoms. A positive skin prick test is defined as a wheal sum 3 mm in diameter greater than diluent control.
✓. Negative urine pregnancy test at all visits for female participants of reproductive potential.

Exclusion criteria

✕. Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
✕. Quantitative skin prick titration with a positive reaction to an allergen concentration of 0.056 bioequivalent allergy units (BAU) or allergy units (AU) per ml.
✕. Other lung diseases, including but not limited to sarcoidosis, bronchiectasis and active lung infection.
✕. History of a respiratory tract infection within 6 weeks of Study Visits #1 and #2.
✕. Participant reported current diagnosis or history of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis, or liver disease.
✕. Participant reported history of coagulopathy, thrombocytopenia or pulmonary hypertension.
✕. Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam.
✕. Laboratory values within 12 weeks prior to Study Visits #1 and #2 that demonstrate:

What they're measuring

Dendritic cell number and phenotype

Timeframe: 18 months

Dendritic cell function

Timeframe: 18 months

Immune composition of the airway

Timeframe: 18 months

Mediators of organized airway immune tissue formation

Timeframe: 18 months

Organized airway immune tissue

Timeframe: 18 months

Trial details

NCT IDNCT04619017

SponsorJOSALYN CHO

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-08

View on ClinicalTrials.gov More Allergic Asthma trials

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participant must be able to understand and provide informed consent.
✓. Age between 18 and 50 years.
✓. Clinical history of at least one of the following reactions to cat dander or dust mite:
✓. Allergic rhinitis, with one or more of nasal congestion, sneezing, runny nose or post- nasal drainage,
✓. Allergic conjunctivitis, with one or more of ocular itching, tearing or swelling, or
✓. Urticarial reactions to contact with cats.
✓. Positive allergen prick test to the allergen causing clinical symptoms. A positive skin prick test is defined as a wheal sum 3 mm in diameter greater than diluent control.
✓. Negative urine pregnancy test at all visits for female participants of reproductive potential.

Exclusion criteria

✕. Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
✕. Quantitative skin prick titration with a positive reaction to an allergen concentration of 0.056 bioequivalent allergy units (BAU) or allergy units (AU) per ml.
✕. Other lung diseases, including but not limited to sarcoidosis, bronchiectasis and active lung infection.
✕. History of a respiratory tract infection within 6 weeks of Study Visits #1 and #2.
✕. Participant reported current diagnosis or history of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis, or liver disease.
✕. Participant reported history of coagulopathy, thrombocytopenia or pulmonary hypertension.
✕. Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam.
✕. Laboratory values within 12 weeks prior to Study Visits #1 and #2 that demonstrate: