Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed)

Phase 2 Completed 539 enrolled Bayer

RandomizedParallel-groupOpen-labelTreatment

Summary

The trial will evaluate the nasal congestion symptom relief of the approved 10 mg phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo in participants with histories of seasonal allergic rhinitis, using loratadine as background medication.

Timeline

Start: 2011-03
Primary completion: 2011-05
Completion: 2011-06

Outcome

Missed primary endpoint

paper None of the PE HCl treatment groups had a statistically significant change from baseline in instantaneous or reflective nasal congestion scores compared with the placebo group. PMID 26143019 ↗

Publications

Meltzer EO, Ratner PH, McGraw T. Oral Phenylephrine HCl for Nasal Congestion in Seasonal Allergic Rhinitis: A Randomized, Open-label, Placebo-controlled Study. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):702-8. doi: 10.1016/j.jaip.2015.05.007. Epub 2015 Jul 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Phenylephrine	Small molecule	10 mg	Oral
Subject	Phenylephrine	Small molecule	20 mg	Oral
Subject	Phenylephrine	Small molecule	30 mg	Oral
Subject	Phenylephrine	Small molecule	40 mg	Oral
Background	Loratadine	Small molecule	10 mg	Oral