Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction
Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nasal Obstruction Present Finding
Intervention: oxymetazoline (Drug); Placebo nasal spray (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Mahidol University Official(s) and/or principal investigator(s): Torpong Thongngarm, M.D., Principal Investigator, Affiliation: Mahidol University Panitan Pradubpongsa, M.D., Study Chair, Affiliation: Mahidol University Paraya Assanasen, M.D., Study Chair, Affiliation: Mahidol University Pongsakorn Tantilipikorn, M.D., Study Chair, Affiliation: Mahidol University
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).
Clinical Details
Official title: Effectiveness of Oxymetazoline Added on Intranasal Steroid in the Treatment of Allergic and Nonallergic Rhinitis With Persistent Nasal Obstruction
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction
Secondary outcome: The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
Additional Information
Starting date: April 2013
Last updated: January 3, 2015
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