Effect of Loratadine/Montelukast Combination on Congestion in SAR Patients Exposed to Pollen in an EEU (Study P04822)
Status:
Completed
Trial end date:
2007-03-10
Target enrollment:
Participant gender:
Summary
This is study of LMC, phenylephrine, and placebo in subjects with SAR. There are three
visits: At Visit 1, subjects will be evaluated for participation and, if they qualify, will
attend Visit 2 for priming. At Visit 2, ragweed pollen will be fed continuously and dispensed
into the environmental exposure unit to induce an allergic reaction. Pollen counts will be
monitored and recorded. During the priming visit(s), subjects will be evaluated to determine
if they qualify. If qualified, they will return for Visit 3, where ragweed pollen will be fed
continuously and dispensed into the environmental exposure unit to induce an allergic
reaction. Pollen counts will be monitored and recorded as in the Priming Session. Subjects
will complete symptom evaluations and if qualified, they will receive study medication and
remain in the environmental exposure unit where symptoms will be evaluated for 8 hours after
dosing. PNIF will be evaluated only during the treatment session. Four nasal symptoms
(rhinorrhea, nasal congestion, sneezing, and nasal itching) and three non-nasal symptoms
(itching/burning eyes, tearing/watery eyes, and itching of ears/palate) will be evaluated.
Adverse events will be collected throughout the study to assess safety and tolerability, and
vital signs will be collected at Visit 1 and at the end of Visit 3.