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

Study Overview
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Brief Summary
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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.

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

Conditions
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Post-nasal Drip, Seasonal Allergic Rhinitis, Rhinorrhea

Intervention / Treatment
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* Drug: Desloratadine 2.5 mg
* Drug: Oxybutynin 2.5 mg
* Drug: Placebo for Desloratadine 2.5 mg
* Drug: Placebo for Oxybutynin 2.5 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DL 2.5 mg<br>Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days | Drug: Desloratadine 2.5 mg<br>* Desloratadine 2.5 mg BID<br>* Other names: Clarinex;Drug: Placebo for Oxybutynin 2.5 mg<br>* Placebo BID<br>|
| Active Comparator: OXY 5 mg<br>Placebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days | Drug: Oxybutynin 2.5 mg<br>* Oxybutynin 2.5 mg BID<br>* Other names: Ditropan;Drug: Placebo for Desloratadine 2.5 mg<br>* Placebo BID<br>|
| Experimental: DL 2.5 mg + OXY 2.5 mg<br>Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days | Drug: Desloratadine 2.5 mg<br>* Desloratadine 2.5 mg BID<br>* Other names: Clarinex;Drug: Oxybutynin 2.5 mg<br>* Oxybutynin 2.5 mg BID<br>* Other names: Ditropan;Drug: Placebo for Oxybutynin 2.5 mg<br>* Placebo BID<br>|
| Experimental: DL 2.5 mg + OXY 5 mg<br>Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days | Drug: Desloratadine 2.5 mg<br>* Desloratadine 2.5 mg BID<br>* Other names: Clarinex;Drug: Oxybutynin 2.5 mg<br>* Oxybutynin 2.5 mg BID<br>* Other names: Ditropan;|
| Placebo Comparator: Placebo<br>Placebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days | Drug: Placebo for Desloratadine 2.5 mg<br>* Placebo BID<br>Drug: Placebo for Oxybutynin 2.5 mg<br>* Placebo BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean daily AM/PM Prior post-nasal drip scores averaged over the entire treatment period |  | Days 1 to 7 +/- 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior rhinorrhea averaged over Days 1 to 8 |  | Days 1 to 8 |