Phase 1 Asthma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Group A – People with Allergic Asthma:

• Lung function (a breathing test called FEV1) must measure at least 75% of the expected normal value at the first study visit.
• A clinical history of allergy symptoms related to cats or dust mites, confirmed by a positive skin prick allergy test.
• Little to no lifetime history of cigarette smoking (fewer than 5 pack-years total, and none in the past 5 years).
• Willing and able to provide informed consent to participate.
• Willing to take part in an interview with the lead researcher.
• Aged between 18 and 50 years.

Group B – Healthy Non-Allergic Controls:

• Generally in good overall health, non-allergic (fully negative on a panel of skin prick allergy tests), with no history of allergic rhinitis or asthma.
• No history of allergy symptoms related to cats or dust mites.
• Lifelong non-smoker of cigarettes (fewer than 5 pack-years total, and none in the past 5 years).
• Lung function results (FEV1 and FVC breathing tests) at or above 90% of the expected normal value.
• A methacholine challenge test result showing low airway sensitivity (PC20 greater than 16 mg/ml).
• Aged between 18 and 50 years, matched by age and sex to the asthma group.

Group C – People with Allergies but No Asthma:

• A history of allergic rhinitis (such as nasal congestion, sneezing, runny nose, or postnasal drip), allergic conjunctivitis (eye itching, tearing, or swelling), or contact allergy linked to cat dander or dust mites, confirmed by a positive skin prick test to the same allergen.
• Lung function (FEV1 and FVC breathing tests) at or above 90% of the expected normal value at the first study visit.
• Positive skin prick allergy test to cat dander or dust mite allergen.
• Generally in good overall health.
• Little to no lifetime history of cigarette smoking (fewer than 5 pack-years total, and none in the past 5 years).
• Willing and able to provide informed consent to participate.
• Willing to take part in an interview with the lead researcher.
• Aged between 18 and 50 years.

Who may not be able to join:

• Women of childbearing age who are pregnant, sexually active without using contraception, trying to become pregnant, or currently breastfeeding.
• People who have had an asthma episode or signs of an upper respiratory infection (such as a cold) in the past 6 weeks.
• People who have taken part in a drug or biologic research study in the 30 days before this study.
• People who are allergic or intolerant to albuterol, atropine, lidocaine, fentanyl, or midazolam (medications used during the study).
• People who have taken antihistamine medications within 7 days of the screening visit.
• People with diabetes, heart failure, certain heart rhythm problems, a history of stroke, kidney failure, a history of severe allergic reactions (anaphylaxis), or liver cirrhosis.
• People who have recently used systemic steroids, increased their inhaled steroid use, or taken beta-blockers or MAO inhibitors, or had an asthma flare-up within 1 month of the screening visit.
• People who have used antibiotics for a respiratory illness within 1 month of the first study visit, or had a respiratory infection within 6 weeks of the procedure visits.
• People with a history of a severe asthma attack that required a breathing tube (intubation).
• People with a very high sensitivity on allergy skin-prick testing, reacting to very low allergen concentrations (down to 0.056 BAU or AU/ml).
• People currently taking beta-adrenergic blocking agents or monoamine oxidase inhibitors (certain types of medication).
• People considered unlikely to follow the study requirements reliably.
• People with more than 10 pack-years of cigarette smoking in total, or any smoking in the past 5 years.
• People with regular exposure to secondhand cigarette smoke, or who have indoor furry pets (except dogs, in cases where the person is not allergic to dogs and has a negative skin test to dog allergen). Note: dust mite-allergic participants are encouraged, but not required, to use dust mite-proof covers on their mattress and pillows.
• People with other lung conditions such as sarcoidosis, bronchiectasis, or an active lung infection.
• People who have used the medication Xolair (omalizumab) in the past 6 months.
• People who have received or are currently receiving allergy immunotherapy (allergy shots) for cat or dust mite allergy.
• People who do not speak English.
• People with a history of blood clotting disorders, low platelet counts, high blood pressure in the lungs (pulmonary hypertension), or who are taking blood-thinning or anti-platelet medications.

Additional exclusion for Group B (Healthy Controls):

• Any history of allergy, asthma, nasal disease, or sinus disease.

Additional exclusions for Group C (Allergic, Non-Asthmatic):

• Any history of asthma.
• A methacholine challenge test result showing airway sensitivity above the study threshold (PC20 less than 16 mg/ml).

Important: Always verify eligibility with the trial site directly before applying.