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

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01847131
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 2.5

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Nasal Obstruction Present Finding	Drug: oxymetazoline; Drug: Placebo nasal spray	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Oxymetazoline Added on Intranasal Steroid in the Treatment of Allergic and Nonallergic Rhinitis With Persistent Nasal Obstruction
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: oxymetazoline 0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily	Drug: oxymetazoline; 0.05% Oxymetazoline nasal sprays were commercially available.; Other Names: Iliadin
Placebo Comparator: placebo placebo nasal spray 2 sprays in each nostril twice daily	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.

Outcome Measures

Primary Outcome Measures

1. Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction [6 weeks]

   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

1. The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline [6 weeks]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok		Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Torpong Thongngarm, M.D., Mahidol University
• Study Chair: Panitan Pradubpongsa, M.D., Mahidol University
• Study Chair: Paraya Assanasen, M.D., Mahidol University
• Study Chair: Pongsakorn Tantilipikorn, M.D., Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT01847131
• Other Study ID Numbers: R015532021
• First Posted: May 6, 2013
• Last Update Posted: Jan 5, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Mahidol University: Rhinitis; Oxymetazoline
• Additional relevant MeSH terms: Rhinitis; Nasal Obstruction; Phenylephrine; Oxymetazoline

Study Results

Participant Flow

Recruitment Details	Eligible patients from medical clinic were instructed to record the severity of nasal congestion 3 days prior to randomization. The severity of nasal congestion was recorded on a 0 to 3 scale (0 = no symptom and 3 = severe symptom). Participants who had nasal congestion score of 1 or greater were recruited for randomization.
Pre-assignment Detail	Exclusion if patients with a history suggestive of cardiovascular, hepatic or renal diseases, pregnant or lactating women, taking oral or nasal decongestant within 7 days, treated with immunotherapy, patients with nasal polyp or significant deviated nasal septum and patient with a history of upper respiratory tract infection within 14 days.

Arm/Group Title	Oxymetazoline	Placebo
Arm/Group Description	0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available.	placebo nasal spray 2 sprays in each nostril twice daily 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.
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Oxymetazoline	Placebo	Total
Arm/Group Description	0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available.	placebo nasal spray 2 sprays in each nostril twice daily 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.	Total of all reporting groups
Overall Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	24 96%	24 96%	48 96%
>=65 years	1 4%	1 4%	2 4%
Sex: Female, Male (Count of Participants)
Female	21 84%	21 84%	42 84%
Male	4 16%	4 16%	8 16%
Region of Enrollment (participants) [Number]
Thailand	25 100%	25 100%	50 100%
nasal congestion scores (units on a scale) [Geometric Mean (Standard Deviation) ]
Geometric Mean (Standard Deviation) [units on a scale]	1.73 (0.54)	1.78 (0.64)	1.76 (0.59)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxymetazoline	Placebo
Arm/Group Description	0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available.	placebo nasal spray 2 sprays in each nostril twice daily 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.
Measure Participants	25	25
Geometric Mean (95% Confidence Interval) [units on a scale]	1.38	1.67

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxymetazoline	Placebo
Arm/Group Description	0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available.	placebo nasal spray 2 sprays in each nostril twice daily 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.
Measure Participants	25	25
Number [participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	Oxymetazoline		Placebo
Arm/Group Description	0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available.		placebo nasal spray 2 sprays in each nostril twice daily 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.
All Cause Mortality
	Oxymetazoline		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Oxymetazoline		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Oxymetazoline		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/25 (68%)		20/25 (80%)
General disorders
Insomnia	1/25 (4%)	1	0/25 (0%)	0
Numbness at lips or tongue	1/25 (4%)	1	1/25 (4%)	1
Nervous system disorders
Headache	1/25 (4%)	1	3/25 (12%)	3
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection	9/25 (36%)	9	9/25 (36%)	9
Nasal discomfort	5/25 (20%)	5	6/25 (24%)	6
Epistaxis	0/25 (0%)	0	1/25 (4%)	1

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.