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
| Verified date | January 2015 |
| Source | Mahidol University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Thailand: Ethical Committee |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Mahidol University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction | 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. | 6 weeks | Yes |
| Secondary | The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline | 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). | 6 weeks | Yes |