Clinical trial NCT01847131: Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction
Official title: Effectiveness of Oxymetazoline Added on Intranasal Steroid in the Treatment of Allergic and Nonallergic Rhinitis With Persistent Nasal Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasal Obstruction Present Finding
Keywords: Rhinitis
Oxymetazoline
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 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

Primary outcomes:
measure: Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction
timeFrame: 6 weeks
Secondary outcomes:
measure: The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Torpong Thongngarm, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol University
name: Panitan Pradubpongsa, M.D.
role: STUDY_CHAIR
affiliation: Mahidol University
name: Paraya Assanasen, M.D.
role: STUDY_CHAIR
affiliation: Mahidol University
name: Pongsakorn Tantilipikorn, M.D.
role: STUDY_CHAIR
References: