Nasal Obstruction Present Finding
Conditions
Keywords
Rhinitis, Oxymetazoline
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.
Interventions
DRUGoxymetazoline
0.05% Oxymetazoline nasal sprays were commercially available.
DRUGPlacebo 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.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Thailand
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Oxymetazoline 0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily
oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available. | 25 |
| 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. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Oxymetazoline | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 24 Participants | 48 Participants |
| nasal congestion scores | 1.73 units on a scale STANDARD_DEVIATION 0.54 | 1.78 units on a scale STANDARD_DEVIATION 0.64 | 1.76 units on a scale STANDARD_DEVIATION 0.59 |
| Region of Enrollment Thailand | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 21 Participants | 21 Participants | 42 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 25 | 20 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
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.
Time frame: 6 weeks
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Oxymetazoline | Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction | 1.38 units on a scale |
| Placebo | Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction | 1.67 units on a scale |
Secondary
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).
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxymetazoline | The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline | 0 participants |
| Placebo | The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline | 0 participants |