Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)

Pilot Efficacy and Safety Field Trial of Desloratadine Administered Concomitantly With Oxybutynin, in Subjects With Seasonal Allergic Rhinitis and Post-Nasal Drip

This was a 1-week study of desloratadine (DL) plus oxybutynin (OXY) at two dose levels in the treatment of post-nasal drip in participants with seasonal allergic rhinitis. Participants received either desloratadine twice a day, oxybutynin twice a day, desloratadine plus lower-dose oxybutynin twice a day, desloratadine plus higher-dose oxybutynin twice a day, or placebo for 7 days.

Inclusion Criteria:

Subjects must:

• be >=18 years of age,
• be free of any clinically significant disease that would interfere with study, other than seasonal allergic rhinitis (SAR),
• have a documented diagnosis of SAR for >=2 years,
• have had a positive skin-prick test,
• be sufficiently symptomatic at the Screening visit,
• for the 3 calendar days immediately prior to baseline visit, plus the AM of the baseline visit, the seven twice-daily run-in diary PRIOR total nasal symptom scores must have totaled >=42, the Total Non-Nasal Symptoms score must have totaled >=28, and the total Post Nasal Drip score must have totaled >=14,
• be in general good health.

Exclusion Criteria:

Subjects who have:

• certain medical conditions or medical histories,
• allergies to any of the components in any of the study medications,
• nasal structure abnormalities,
• dependency to nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids,
• used any investigational drug use in past 30 days,
• received immunotherapy (desensitization)
• are pregnant