Nasal Congestion Due to Allergic Rhinitis Clinical Trial
Official title:
A Multicenter, Consumer Product Evaluation of a Single Dose of Phenylephrine Hydrochloride 30 mg Extended Release Tablets (Sinus Comfort™)
The researchers in this study want to find out whether participants with a history of stuffy
nose due to allergic reactions in the nose would intend to buy drug Phenylephrine
Hydrochloride (Phenylephrine HCl) extended release tablet (a pill is formulated so that the
drug is released slowly over time) after receiving it once in this study. Phenylephrine HCl
is an over-the-counter (OTC) drug (a medicine that can be bought without a prescription) used
to provide temporary relief of stuffy nose caused by cold or allergies in mouth, nose and
throat. Phenylephrine HCl immediate-release tablet (a pill with drug released rapidly without
special rate controlling) was already approved to be used for adults and children and the
recommended dose for adults and children 12 years or older is 10mg every 4 hours.
Phenylephrine HCl 30mg extended release tablet used in this study is not yet approved but
under development with a goal to relieve stuffy nose for every 8 hours. Researchers also want
to find out if participants have any medical problems during the trial.
Participants in this study will be asked to record their stuffy nose symptoms in a diary
before and after drug intake. At 8 hours after drug intake, participants need to assess
whether they intends to buy the drug or not and their overall satisfaction of the stuffy nose
relief. At the end the participants will complete a questionnaire about their job, learning
background, income and medical history of stuffy nose.
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