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

NCT01847131 | Completed Phase 4 Results

• 1 other identifier: R015532021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Nasal Obstruction Present Finding

Keywords

Rhinitis; Oxymetazoline

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline

  6 weeks

Study Arms (2)

oxymetazoline

ACTIVE COMPARATOR

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

Drug: oxymetazoline

placebo

PLACEBO COMPARATOR

placebo nasal spray 2 sprays in each nostril twice daily

Drug: Placebo nasal spray

Interventions

oxymetazoline DRUG

0.05% Oxymetazoline nasal sprays were commercially available.

Also known as: Iliadin

oxymetazoline

Placebo nasal spray 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.

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Nasal Obstruction; Rhinitis

Interventions

Oxymetazoline

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Further studies with larger numbers of subjects and longer period of follow-up would probably have led to significant differences between both treatment groups in NPIF, Rcq scores and the possible rebound nasal congestion or other adverse events.

Results Point of Contact

• Title: Torpong Thongngarm, M.D.
• Organization: Faculty of Medicine Siriraj Hospital, Mahidol University

torpong.tho@mahidol.ac.th

66-2-419-8263

Study Officials

• Torpong Thongngarm, M.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

• Panitan Pradubpongsa, M.D.

  Mahidol University

  STUDY CHAIR

• Paraya Assanasen, M.D.

  Mahidol University

  STUDY CHAIR

• Pongsakorn Tantilipikorn, M.D.

  Mahidol University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2013
• First Posted: May 6, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 5, 2015
• Results First Posted: January 5, 2015

Record last verified: 2015-01

Locations

TH (1)