Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction
Primary Purpose
Nasal Obstruction Present Finding
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
oxymetazoline
Placebo nasal spray
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Obstruction Present Finding focused on measuring Rhinitis, Oxymetazoline
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
Sites / Locations
- Faculty of Medicine Siriraj Hospital, Mahidol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
oxymetazoline
placebo
Arm Description
0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily
placebo nasal spray 2 sprays in each nostril twice daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01847131
Brief Title
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
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction Present Finding
Keywords
Rhinitis, Oxymetazoline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oxymetazoline
Arm Type
Active Comparator
Arm Description
0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo nasal spray 2 sprays in each nostril twice daily
Intervention Type
Drug
Intervention Name(s)
oxymetazoline
Other Intervention Name(s)
Iliadin
Intervention Description
0.05% Oxymetazoline nasal sprays were commercially available.
Intervention Type
Drug
Intervention Name(s)
Placebo nasal spray
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline
Description
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).
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torpong Thongngarm, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Panitan Pradubpongsa, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paraya Assanasen, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pongsakorn Tantilipikorn, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
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Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction
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