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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Mahidol University

Current Primary Outcome: Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction [ Time Frame: 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.


Original Primary Outcome: Effectiveness and safety of oxymetazoline in the treatment of rhinitis with persistent nasal obstruction [ Time Frame: 6 weeks ]

Primary outcome measure is the percentage of rhinitis patients who have improved nasal congestion score measuring by visual analog scale (VAS)compared between treatment group and controlled group. We also give patients Incheck peak inspiratory peak flow meter to measure and record nasal peak inspiratory flow (NPIF) daily which is an objective parameter for nasal congestion. Furthermore the quality of life questionnaire (RCQ36), a validated questionnaire, will be used to measure Qol score prior to start the study and every follow-up visit. During follow-up visits, patients will be asked for any possible adverse effects and events of the study medication and thorough physical examination including blood pressure measurement will be performed.


Current Secondary Outcome: The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline [ Time Frame: 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).


Original Secondary Outcome: Incidence of rhinitis medicamentosa after using oxymetazoline [ Time Frame: 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 whether patients develop rebound nasal congestion.


Information By: Mahidol University

Dates:
Date Received: April 14, 2013
Date Started: April 2013
Date Completion:
Last Updated: January 3, 2015
Last Verified: January 2015