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.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis; Rhinorrhea; Post-nasal Drip
• Intervention / Treatment: Drug: Desloratadine 2.5 mg; Drug: Placebo for Oxybutynin 2.5 mg; Drug: Oxybutynin 2.5 mg; Drug: Placebo for Desloratadine 2.5 mg

• Study Type: Interventional
• Enrollment (Actual): 540
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DL 2.5 mg; Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days	Drug: Desloratadine 2.5 mg; Desloratadine 2.5 mg BID; Other Names: SCH 034117; Clarinex; Drug: Placebo for Oxybutynin 2.5 mg; Placebo BID
Active Comparator: OXY 5 mg; Placebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days	Drug: Oxybutynin 2.5 mg; Oxybutynin 2.5 mg BID; Other Names: Ditropan; Drug: Placebo for Desloratadine 2.5 mg; Placebo BID
Experimental: DL 2.5 mg + OXY 2.5 mg; 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; Desloratadine 2.5 mg BID; Other Names: SCH 034117; Clarinex; Drug: Placebo for Oxybutynin 2.5 mg; Placebo BID; Drug: Oxybutynin 2.5 mg; Oxybutynin 2.5 mg BID; Other Names: Ditropan
Experimental: DL 2.5 mg + OXY 5 mg; Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days	Drug: Desloratadine 2.5 mg; Desloratadine 2.5 mg BID; Other Names: SCH 034117; Clarinex; Drug: Oxybutynin 2.5 mg; Oxybutynin 2.5 mg BID; Other Names: Ditropan
Placebo Comparator: Placebo; Placebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days	Drug: Placebo for Oxybutynin 2.5 mg; Placebo BID; Drug: Placebo for Desloratadine 2.5 mg; Placebo BID

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: January 5, 2009
• First Submitted That Met QC Criteria: January 5, 2009
• First Posted (Estimate): January 6, 2009

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Rhinorrhea; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Anti-Infective Agents, Urinary; Renal Agents; Oxybutynin; Desloratadine; Loratadine; Mandelic Acids
• Other Study ID Numbers: P04258