Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit

Exclusion Criteria

• •Clinically significant medical condition (such as cardiovascular, hepatic, neurologic, hematological, renal, gastrointestinal, endocrine, or other major systemic disease), which, in the judgment of the investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult
• •Asthma that requires treatment with medication other than an inhaled, short-acting beta agonist or asthma that will be exacerbated by exposure to ragweed pollen
• •Pregnancy or breast-feeding
• •History of hypersensitivity to the study medications or to drugs with similar chemical structures
• •Nasal structural abnormalities, including large nasal polyps or marked septal deviation, that significantly interfere with nasal air flow
• •Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
• •Upper or lower respiratory infection within 14 days of the first priming visit
• •Diagnosis of sinusitis within 30 days of the first priming visit
• •Immunotherapy, except those on a constant dose of immunotherapy that will be maintained throughout the study
• •Treatment with any investigational drug in the last 30 days before study entry
• •Recent history of drug or alcohol abuse
• •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
• •Unlikelihood to comply with protocol such as those with uncooperative attitude or the inability to return for follow-up visits or to complete the study
• •Subjects who were randomized into this trial will not be eligible to participate in another fexofenadine hydrochloride 180 mg vs montelukast sodium 10 mg onset of action study (planned to be conducted in 2003)
• •Subjects who are research employees or relatives of study site staff involved in this study or those who have or will read the protocol