NCT01469234

A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)

A Double-Blind, Parallel, Randomized, Placebo Controlled Trial to Evaluate Onset of Action of Loratadine and Fexofenadine in Subjects With Seasonal Allergic Rhinitis in a Pollen Challenge Chamber

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug.

Conditions

• Rhinitis

Interventions

Type	Name	Description
DRUG	loratadine	loratadine, one 10 mg tablet, orally
DRUG	fexofenadine	fexofenadine, one 180 mg tablet, orally
DRUG	placebo to loratadine	one tablet, orally
DRUG	placebo to fexofenadine	one tablet, orally

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-11-10
• Last updated: 2015-03-11
• Results posted: 2013-03-22