Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction
Condition: Nasal Obstruction Present Finding
MeSH terms: Rhinitis; Nasal Obstruction
Intervention: oxymetazoline; Placebo nasal spray
Intervention description: 0.05% Oxymetazoline nasal sprays were commercially available.; 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.
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rhinitis; Oxymetazoline

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).
    

Eligibility criteria:

        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