Induced Sputum Study (0000-065)
Induced Sputum Study (0000-065)
The primary goals of this study will be to implement innovative processing and detection
 assays to qualify induced sputum measurements of markers of allergen-induced airway
 inflammation. The results of this study are intended to form a platform to be used in the
 clinical development of novel asthma therapeutics.
Inclusion Criteria:

 -  Patient has a history of mild to moderate persistent allergic asthma for at least 6
 months with typical symptoms, including cough, wheezing, and shortness of breath, is
 clinically stable and has no history of recent respiratory tract infection within 3
 weeks of the start of the study

 -  Patient, aside history of asthma, is judged to be in good health based on medical
 history, physical examination, vital sign measurements, and laboratory safety tests.

 -  Patient is able to perform reproducible pulmonary function test.

 -  Patient has an allergic response to house dust mite allergen, demonstrates a positive
 early and late phase response to an inhaled allergen challenge (as defined by a
 bronchoconstrictive response)

 -  Patient is a nonsmoker for at least 12 months. Patients must have less than or equal
 to 10 pack years of smoking to be included. (10 pack years = one pack per day for 10
 years.) Patients who have discontinued smoking for at least 10 months may be enrolled
 at the discretion of the investigator

 -  Patient is willing to avoid strenuous physical activity (i.e., strenuous or
 unaccustomed weight lifting, running, bicycling, etc.) for 72 hours prior to each
 visit when laboratory safety tests are obtained and 48 hours prior to allergen
 challenge

 Exclusion Criteria:

 -  Patient has a history of any illness that, in the opinion of the study investigator,
 might confound the results of the study or poses additional risk to the patient by
 their participation in the study

 -  Patient has taken oral corticosteroids within 8 weeks or inhaled corticosteroids/nasal
 corticosteroids within 4 weeks of screening and/or during the study

 -  Patient has a history of stroke, chronic seizures, or major neurological disorder

 -  Patient has a history of clinically significant endocrine, gastrointestinal,
 cardiovascular, hematological, hepatic, immunological, renal, respiratory (other than
 asthma), or genitourinary abnormalities or diseases, or has a history of neoplastic
 disease

 -  Patient is unable to refrain from or anticipates the use of any medication other than
 the ones permitted in this study, including prescription and non-prescription drugs or
 herbal remedies prior to administration of the initial dose of study drug, throughout
 the study (including washout intervals between treatment periods), until the poststudy
 visit

 -  Patient consumes excessive amounts of alcohol, defined as greater than 3 glasses of
 alcoholic beverages per day or >21 drink equivalents per week.

 -  Patient consumes excessive amounts, defined as greater than 6 servings of coffee, tea,
 cola, or other caffeinated beverages per day