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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxymetazoline | Active Comparator | 0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily |
|
| placebo | Placebo Comparator | placebo nasal spray 2 sprays in each nostril twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxymetazoline | Drug | 0.05% Oxymetazoline nasal sprays were commercially available. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok | Bangkok | 10700 | Thailand |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxymetazoline | 0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline analysis were performed to compared between 2 groups on age, gender results of allergy skin tests and baseline nasal congestion scores.
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxymetazoline | 0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age, gender, allergy skin prick testing for aeroallergens and baseline nasal congestion scores were measured. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Geometric Mean | 95% Confidence Interval | units on a scale | 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxymetazoline | 0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Upper respiratory tract infection including common cold, pharyngitis, etc |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Torpong Thongngarm, M.D. | Faculty of Medicine Siriraj Hospital, Mahidol University | 66-2-419-8263 | torpong.tho@mahidol.ac.th |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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| ID | Term |
|---|---|
| D010109 | Oxymetazoline |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. |
|
| 6 weeks |
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.
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| nasal congestion scores | The severity of nasal congestion was recorded on a 0 to 3 scale (0 = no symptom, 1= mild symptom, 2 = moderate symptom and 3 = severe symptom). | Geometric Mean | Standard Deviation | 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). | Posted | Number | participants | 6 weeks |
|
|
|
| 0 |
| 25 |
| 17 |
| 25 |
| EG001 | 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. | 0 | 25 | 20 | 25 |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Nasal discomfort includes nasal irritation and nasal pain. |
|
| Headache | Nervous system disorders | Systematic Assessment | Headache includes functional headache without localizing signs. |
|
| Insomnia | General disorders | Systematic Assessment | Difficulty of sleep without other specific symptoms. |
|
| Numbness at lips or tongue | General disorders | Systematic Assessment | The sense of numbness at lips or tongue without neurological localizing sign. |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Epistaxis due to local irritation. |
|
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| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |