Nasal Obstruction Present Finding Clinical Trial
Official title:
Effectiveness of Oxymetazoline Added on Intranasal Steroid in the Treatment of Allergic and Nonallergic Rhinitis With Persistent Nasal Obstruction
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).
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment