Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergi… (NCT00595491) | Clinical Trial Compass
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
United States313 participantsStarted 2008-01
Plain-language summary
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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕. 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.
✕. Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam.
✕. Antihistamines within 7 days of the screening visit.
. Presence of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis, or cirrhosis.
✕. 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.
✕. Antibiotic use for respiratory disease within 1 month of the characterization visit or a respiratory tract infection within 6 weeks of the bronchoscopy visits.