CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 19 enrolled
Drug / intervention
Oxymetazoline 0.05% w/v +3 moredrug
Likely dose
Fluticasone propionate 50 micrograms per actuationfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00487032
NCT00487032Phase 4Completed

A Proof of Concept Study to Evaluate Differential Tachyphylaxis of Alpha 1 and Alpha 2 Adrenoreceptor Mediated Decongestant Response to Oxymetazoline and Its Acute Reversal by Corticosteroid in Healthy Volunteers

Brian J Lipworth·interventional·Posted Jun 15, 2007·Updated Apr 12, 2019

In Brief

A Phase 4 clinical trial evaluating Oxymetazoline 0.05% w/v, Fluticasone propionate 50 micrograms per actuation, and 2 other interventions for Allergic Rhinitis and 2 related conditions. Completed, enrolled 19 participants across 2 sites.

Detailed Summary

The investigators wish to evaluate the onset of tolerance to nasal decongestants like oxymetazoline (available over the counter) and the mechanism of tolerance particularly with differential effects on alpha 1 and alpha 2 adrenoreceptors on the nose. The investigators will 'tease' out by using an alpha 1 blocker called Prazosin. The investigators hypothesize that alpha 1 receptors mediate arterial constriction and this will be captured by measuring nasal blood flow. The investigators also hypothesize that alpha 2 receptors mediate venous sinusoid constriction and this the investigators will capture by airflow parameters like Peak Nasal Inspiratory Flow, Rhinomanometry, Oscillometric indices etc.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 15, 2007
Enrollment StartMay 1, 2008
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 19.0 years ago

Interventions

Oxymetazoline 0.05% w/vdrug

2 squirts in each nostril thrice daily

Fluticasone propionate 50 micrograms per actuationdrug

2 Squirts in each nostril twice daily

Prazosin hydrochloridedrug

Prazosin 1mg one dose only

Placebo to Prazosindrug

Placebo 1 tablet one dose only