Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
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).