Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction

Phase 4

Completed

Conditions: Nasal Obstruction Present Finding

Interventions: Drug: Placebo nasal spray
Drug: oxymetazoline

Registration Number: NCT01847131

Lead Sponsor: Mahidol University

Brief 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).

Detailed Description: All participants will continue medications for 4 weeks, then stop using interventional medication and still take INS (2 puffs in each nostril twice daily) and OAH (1 tablet once daily) for 2 more weeks. Then, all participants will come for the last visit to see whether rebound nasal symptoms occur. Participants will be asked to record nasal symptom diary card, and nasal peak inspiratory flow. Rhinoconjunctivitis Quality of life Questionnaire (Rcq) will be recorded during visit.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patient 18 years of age or greater
Diagnosis with allergic or nonallergic rhinitis with persistent nasal obstruction
Being treated with intranasal steroid and oral antihistamine

Exclusion Criteria

Underlying disease of hypertension
Use oral or nasal decongestant 7 days prior to entering the study
Nasal polyp or significant deviated nasal septum
Respiratory tract infection 14 days prior to entering the study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo nasal spray	placebo nasal spray 2 sprays in each nostril twice daily
oxymetazoline	oxymetazoline	0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily

Primary Outcome Measures

Name	Time	Method
Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction	6 weeks	Primary outcome measure is the nasal congestion score measuring by visual analog scale (VAS) ranging from 1-10 (0 = no symptom and 10 = the most severe symptom) compared between treatment group and controlled group.

Secondary Outcome Measures

Name	Time	Method
The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline	6 weeks	Rhinitis medicamentosa is the rebound nasal congestion after prolonged use (\>7 days) of topical nasal decongestant (eg. oxymetazoline). However, a previous study by Baroody FM et al (J Allergy Clin Immunol 2011;127:927-34) showed that using oxymetazoline together with intranasal steroid for 1 month did not increase rhinitis medicamentosa compared to placebo. So we give rhinitis patients in the treatment group with oxymetazoline and intranasal steroid for 1 month, then stop using oxymetazoline and come back for the last visit 2 weeks later to see which patients develop rebound nasal congestion (rhinitis medicamentosa).