Trial Outcomes & Findings for Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction (NCT NCT01847131)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

6 weeks

Results posted on

2015-01-05

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Oxymetazoline 0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available.	Placebo 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.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxymetazoline n=25 Participants 0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available.	Placebo n=25 Participants 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 n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Thailand	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
nasal congestion scores	1.73 units on a scale STANDARD_DEVIATION 0.54 • n=5 Participants	1.78 units on a scale STANDARD_DEVIATION 0.64 • n=7 Participants	1.76 units on a scale STANDARD_DEVIATION 0.59 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Oxymetazoline n=25 Participants 0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available.	Placebo n=25 Participants 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.
Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction	1.38 units on a scale Interval 0.95 to 1.81	1.67 units on a scale Interval 1.19 to 2.15

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Oxymetazoline n=25 Participants 0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available.	Placebo n=25 Participants 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.
The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline	0 participants	0 participants

Adverse Events

Oxymetazoline

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oxymetazoline n=25 participants at risk 0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available.	Placebo n=25 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	36.0% 9/25 • Number of events 9	36.0% 9/25 • Number of events 9
Respiratory, thoracic and mediastinal disorders Nasal discomfort	20.0% 5/25 • Number of events 5	24.0% 6/25 • Number of events 6
Nervous system disorders Headache	4.0% 1/25 • Number of events 1	12.0% 3/25 • Number of events 3
General disorders Insomnia	4.0% 1/25 • Number of events 1	0.00% 0/25
General disorders Numbness at lips or tongue	4.0% 1/25 • Number of events 1	4.0% 1/25 • Number of events 1
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/25	4.0% 1/25 • Number of events 1

Additional Information

Torpong Thongngarm, M.D.

Faculty of Medicine Siriraj Hospital, Mahidol University

Phone: 66-2-419-8263

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place