CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
oxymetazoline +1 moredrug
Likely dose
Not stated in 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/NCT01847131
NCT01847131Phase 4Completed

Effectiveness of Oxymetazoline Added on Intranasal Steroid in the Treatment of Allergic and Nonallergic Rhinitis With Persistent Nasal Obstruction

Mahidol University·interventional·Posted May 6, 2013·Updated Jan 5, 2015

In Brief

A Phase 4 clinical trial evaluating oxymetazoline and Placebo nasal spray for Nasal Obstruction Present Finding. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Background Allergic rhinitis is a common health problem with a worldwide prevalence is 10-25%, and poses significant impact on the quality of life of the patients. In Thailand, the prevalence of allergic rhinitis in the general population is 13.5%, of which the frequency of allergic rhinitis increased from 23% to 38% in the children, and 61.9% in the graduate students. Despite intranasal steroid being the current first-line treatment of patients with allergic rhinitis, only 60% of patients achieve excellent control. Persistent nasal congestion is the major symptom which is difficult to control in these patients. Data are limited about efficacy and safety of the additional use of 0.05% intranasal oxymetazoline hydrochloride (OXY) for persistent nasal congestion that does not adequately respond to recommended doses of intranasal steroid (INS) and oral antihistamine(OAH). Objective To determine the efficacy and safety of the additional use of OXY for persistent nasal congestion in allergic rhinitis or non-allergic rhinitis patients inadequately controlled by combination treatment with INS and OAH. Methods The investigators performed a 6-week, randomized, double blind, placebo controlled, clinical trial in 50 patients with allergic rhinitis or non-allergic rhinitis whom inadequately controlled by combination treatment with INS and oral antihistamine (OAH). After an initial screening, qualified individuals were randomized into 2 groups including the treatment group and the control group. The treatment group received the INS (2 puffs in each nostril twice daily) and OAH (1 tablet once daily) plus OXY (2 puffs in each nostril twice daily) The control group received INS (2 puffs in each nostril twice daily) and OAH (1 tablet once daily) plus placebo (2 puffs in each nostril twice daily).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesThailand
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 6, 2013
Enrollment StartApr 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.2 years ago

Interventions

oxymetazolinedrug

0.05% Oxymetazoline nasal sprays were commercially available.

Placebo nasal spraydrug

Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient.