Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Recruiting
Phase 1Interventional Study
Asthma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 50
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
313 (estimated)
Sponsor
Benjamin Medoff · Other
Who this trial is looking for
This trial is looking for individuals with allergic asthma and related allergies, as well as healthy volunteers. Participants will undergo interviews and various health assessments to help researchers understand airway inflammation.
Are You a Good Fit for This Trial?
Must not be takingAntihistamines
Rules you outDiabetesHeart failureCirrhosisAsthma
You may be able to join if
I have allergic asthma
I have experienced allergic symptoms to cat or dust mite allergens
I am between 18 and 50 years old
I do not smoke cigarettes
I can provide informed consent
I want to participate in an interview with the researcher
I have a baseline lung function of at least 75% of the predicted value
You may not be able to join if
I am pregnant or nursing
I have had a respiratory infection in the last 6 weeks
I am taking antihistamines
I have a history of asthma-related respiratory failure
I have diabetes, heart failure, or other serious health issues
I have participated in another study involving a drug in the last 30 days
I have a history of allergic reactions that require emergency treatment
I have a positive allergy test to other allergens
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Asthma is a heterogeneous disorder in which multiple potential inflammatory pathways contribute to airway obstruction. The biological basis for airway inflammation is the subject of intensive investigation. This work is designed to identify airway factors that are responsible for recruiting cells and associate their airway presence with atopy and asthma.
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Eligibility Criteria
A. Subjects with Allergic Asthma (AA subjects)
Inclusion Criteria:
1. All subjects will have a baseline FEV1 determined at the characterization visit that is no less than 75 % of the predicted value.
2. All subjects will have a clinical history of allergic symptoms to cat or dust mite allergen and…
A. Subjects with Allergic Asthma (AA subjects)
Inclusion Criteria:
1. All subjects will have a baseline FEV1 determined at the characterization visit that is no less than 75 % of the predicted value.
2. All subjects will have a clinical history of allergic symptoms to cat or dust mite allergen and demonstrated skin reactivity (a positive allergen prick test).
3. Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years); none in 5 years).
4. Willing and able to give informed consent.
5. Expressed the desire to participate in an interview with the principal investigator.
6. Age between 18 and 50 years.
Exclusion Criteria:
1. Women of childbearing potential who are documented to be pregnant (based on Urine beta-HCG testing), are sexually active and not using contraception, are seeking to become pregnant, or who are nursing.
2. The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract infection within the previous 6 weeks.
3. Participation in research study involving a drug or biologic during the 30 days prior to the study.
4. Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam.
5. Antihistamines within 7 days of the screening visit.
6. Presence of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis, or cirrhosis.
7. Use of systemic steroids, increased use of inhaled steroids, beta blockers and MAO inhibitors or a visit for an asthma exacerbation within 1 month of the screening visit.
8. Antibiotic use for respiratory disease within 1 month of the characterization visit or a respiratory tract infection within 6 weeks of the bronchoscopy visits.
9. A history of asthma-related respiratory failure requiring intubation.
10. Quantitative skin-prick test positive reaction down to an allergen concentration of 0.056 BAU or AU/ml .
11. Taking beta-adrenergic blocking agents or monoamine oxidase inhibitors.
12. Subjects with a high possibility of poor compliance with the study.
13. No history of cigarette smoking within the past 5 years or \> 10 pack years total.
14. Having second-hand cigarette smoke exposure or indoor furry pets except in the case of dog, if the subject is not allergic to the dog and the subject has a negative skin test to dog (It is also preferred but not required that dust mite allergic subjects have dust mite-proof encasings on their mattress and pillows.)
15. Other lung diseases, such as sarcoidosis, bronchiectasis or active lung infection.
16. Use of Xolair (omalizumab - anti-IgE monoclonal antibody) for 6 months.
17. Immunotherapy with cat or dust mite extract now or in the past.
18. Non-English speakers.
19. History of coagulopathy, thrombocytopenia, pulmonary hypertension, and/or use of anti-coagulants/anti-platelet drugs.
B. Healthy Normal Control Subjects (NC subjects)
Normal control subjects will be individuals who are in good overall health, age and sex matched to the asthmatic group, age 18 - 50 and nonallergic, i.e. entirely negative on the panel of prick skin tests listed in section V (Study Procedures), with no history of allergic rhinitis or asthma, no history of allergic symptoms caused by cats or dust mite allergen exposure, life-long nonsmokers of cigarettes (defined as a lifetime total of less than 5 pack-years and none in 5 years), normal spirometry (i.e. FEV1 and FVC of at least 90% of predicted) and with a methacholine PC20 of \> 16 mg/ml.
Exclusion Criteria:
1. A history of allergy, asthma, nasal or sinus disease.
2. Exclusion criteria #1, 3-8 and 10-19 from (A.) above.
C. Allergic Nonasthmatic Subjects (ANA subjects)
Inclusion Criteria:
1. ANA subjects will have a history of either (a) allergic rhinitis (with one or more of the following symptoms: nasal congestion, sneezing, runny nose, postnasal drainage), (b) allergic conjunctivitis (ocular itching, tearing and/or swelling) or (c) contact allergy associated with cat dander or dust mite and a positive allergy test to the same allergen.
2. All subjects will have a baseline FEV1 and FVC determined at the characterization visit that is no less than 90 % of the predicted value.
3. All subjects will have a positive allergy skin prick test to cat dander or dust mite allergen.
4. All subjects will be in good general health.
5. Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years and none in 5 years).
6. Willing and able to give informed consent.
7. Expressed the desire to participate in an interview with the principal investigator.
8. Age between 18 and 50 years.
Exclusion Criteria:
1. A history of asthma.
2. Exclusion criteria #1, 3-8 and 10-19 from (A.) above.
3. A methacholine PC20 \< 16 mg/ml.
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