Phase 4
N=50
Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction
Nasal Obstruction Present Finding
Bottom Line
View on ClinicalTrials.gov: NCT01847131 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction — 1.38; 1.67 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- oxymetazoline (Drug); Placebo nasal spray (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mahidol University
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction |
1.38; 1.67 | — |
| SECONDARY The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline |
0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01847131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.