Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction

NCT ID: NCT01847131

Last Updated: 2015-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Nasal Obstruction Present Finding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

oxymetazoline

0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily

Group Type: ACTIVE_COMPARATOR

oxymetazoline

Intervention Type: DRUG

0.05% Oxymetazoline nasal sprays were commercially available.

placebo

placebo nasal spray 2 sprays in each nostril twice daily

Group Type: PLACEBO_COMPARATOR

Placebo nasal spray

Intervention Type: DRUG

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.

Interventions

oxymetazoline

0.05% Oxymetazoline nasal sprays were commercially available.

Intervention Type: DRUG

Placebo nasal spray

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 Type: DRUG

Other Intervention Names

Iliadin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Torpong Thongngarm, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Panitan Pradubpongsa, M.D.

Role: STUDY_CHAIR

Mahidol University

Paraya Assanasen, M.D.

Role: STUDY_CHAIR

Mahidol University

Pongsakorn Tantilipikorn, M.D.

Role: STUDY_CHAIR

Mahidol University

Locations

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Countries

Thailand

Other Identifiers

R015532021

Identifier Type: -

Identifier Source: org_study_id