Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation

Prior treatment

• The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract infection within the previous 6 weeks.
• Participation in research study involving a drug or biologic during the 30 days prior to the study.
• 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.
• Taking beta-adrenergic blocking agents or monoamine oxidase inhibitors.
• Use of Xolair (omalizumab - anti-IgE monoclonal antibody) for 6 months.
• Immunotherapy with cat or dust mite extract now or in the past.

Other illness

• Presence of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis, or cirrhosis.
• Antibiotic use for respiratory disease within 1 month of the characterization visit or a respiratory tract infection within 6 weeks of the bronchoscopy visits.
• A history of asthma-related respiratory failure requiring intubation.
• No history of cigarette smoking within the past 5 years or \> 10 pack years total.
• 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.)
• Other lung diseases, such as sarcoidosis, bronchiectasis or active lung infection.
• A history of allergy, asthma, nasal or sinus disease.
• Allergic Nonasthmatic Subjects (ANA subjects)
• A history of asthma.

Lab values

• History of coagulopathy, thrombocytopenia, pulmonary hypertension, and/or use of anti-coagulants/anti-platelet drugs.

Age

• 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.

Other

• 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.
• Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam.
• Antihistamines within 7 days of the screening visit.
• Quantitative skin-prick test positive reaction down to an allergen concentration of 0.056 BAU or AU/ml .
• Subjects with a high possibility of poor compliance with the study.
• Non-English speakers.
• Exclusion criteria #1, 3-8 and 10-19 from (A.) above.
• Exclusion criteria #1, 3-8 and 10-19 from (A.) above.
• A methacholine PC20 \< 16 mg/ml.

• All subjects will have a baseline FEV1 determined at the characterization visit that is no less than 75 % of the predicted value.
• 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).
• Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years); none in 5 years).
• Willing and able to give informed consent.
• Expressed the desire to participate in an interview with the principal investigator.
• Age between 18 and 50 years.
• 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.
• All subjects will have a baseline FEV1 and FVC determined at the characterization visit that is no less than 90 % of the predicted value.
• All subjects will have a positive allergy skin prick test to cat dander or dust mite allergen.
• All subjects will be in good general health.
• Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years and none in 5 years).
• Willing and able to give informed consent.
• Expressed the desire to participate in an interview with the principal investigator.
• Age between 18 and 50 years.

Criteria the registry did not label

• Subjects with Allergic Asthma (AA subjects)