This study will investigate whether changes in inflammatory mediators produced by the nose after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel drugs for the treatment of allergic asthma.

Inclusion Criteria:

• Patient is allergic to Timothy grass pollen
• Female patients have a negative pregnancy test and agree to use birth control throughout the study
• Male patients agree to use birth control throughout the study
• Patient has been a nonsmoker for at least 6 months
• Patient agrees to avoid the use of aspirin and other Non-steroidal anti-inflammatory drugs (NSAIDs) throughout study

Exclusion Criteria:

• Patient is breastfeeding
• Patient has any respiratory disease other than mild stable asthma that does not require treatment
• Patient consumes more than 3 alcoholic beverages per day
• Patient consumes more than 6 caffeinated beverages per day
• Patient has had major surgery or has donated or lost 1 unit of blood within 4 weeks of screening
• Patient has severe allergies

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed.

AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and Electrocardiogram (ECG) at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.

Poor cell yields from nasal lavage significantly reduced the utility of eosinophil count data.