Clinical Research Directory

Inclusion Criteria: Men or women aged 18 to 75 years inclusive at the first screening visit with mild atopic asthma. General good health with no other medical condition, medication use or lifestyle activities that would influence the outcome of the allergen challenge (case by case, investigator discretion) A forced expiratory volume after 1 second greater than 70% predicted at the first screening visit. A methacholine provocative concentration causing a 20% fall in forced expiratory volume in 1 second of ≤ 16 mg/ml during the first methacholine inhalation challenge. Positive skin test to at least one common aeroallergen. A demonstrated (or historic documentation of) early asthmatic response following the allergen inhalation challenge. Agree to withhold use of inhaled short-acting β2-agonist for 8 hours before all study visits where spirometry is performed. Agree to refrain from rigorous exercise 4 hours before all study visits. Nonsmoker or former smoker (former smokers are permitted if nonsmoker for 2 years and \<10 pack-year smoking history). Capable of performing the maneuvers and procedures required by the protocol and have a high probability for compliance with and completion of the study. Exclusion Criteria: Upper or lower respiratory infection or asthma exacerbation within 4 weeks of first study visit. The occurrence of allergic rhinitis, as determined by investigator, will not exclude the subject from the study. Use of any medications for treatment of asthma other than prophylactic short-acting β2-agonists, or intermittent (not more than once weekly) use of short-acting β2-agonists for relief of symptoms. Current or history of lung disease other than mild stable allergic asthma. Smoking within past 12 months, or former smoker with \>10-pack-year history. Known to have tested positive for human immunodeficiency virus or hepatitis. For women only - self-reported pregnancy, breast-feeding, or plans to become pregnant during the study. Reported use of illegal drugs or history of abuse of prescription drugs or alcohol within 1 year before the first screening visit. Any clinically important deviation from normal limits in vital signs. Participation in a research study with an investigational product during the last 30 days or 5 half-lives of the drug (whichever is longer) Inability to produce a sputum sample at the first study visit.