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This study aims to examine the efficacy and safety of commination oxymetazoline/intranasal steroids for long-term management of chronic nasal obstruction that is recalcitrant to the current standard of care. The investigators hypothesize that combination treatment with oxymetazoline and intranasal corticosteroid spray will provide a larger reduction in nasal obstruction than intranasal corticosteroid alone for patients suffering from chronic nasal obstruction, and there will not be occurrences of rhinitis medicamentosa.
Participants will be directed to apply the intranasal spray, at a dosage of two sprays in each nostril, twice daily. The total treatment time for participants in both trial arms is 7 weeks. Participants will be randomized to either 1) oxymetazoline + budesonide intranasal spray or 2) budesonide intranasal spray. Participants will be mailed the intranasal spray directly from the pharmacy. Participants will complete questionnaires via REDCap survey link at baseline, Week 2, Week 4, Week 5, Week 6, and Week 7. A group of 10 participants will be asked to have nasal mucosal biopsies done at baseline and between weeks 4 and 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| budesonide + oxymetazoline, | Experimental | alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC). |
|
| budesonide | Active Comparator | intranasal corticosteroid that is available OTC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymetazoline Nasal Spray | Drug | Intra-nasal alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Responders | The primary outcome measure will be the rate of responders (as a percentage) to the intervention defined as the number of participants reporting 2 (Moderately Improved), or 3 (Much Improved) in the Clinical Global Impression of Improvement (CGI-I) assessed after 4 weeks of treatment divided by the total number of participants in each study group. CGI-I asks subjects to rate their overall response to treatment using a 7-point Likert scale ranging from -3 to 3 ("Much Worse" to "Much Improved"). Participants responding 2 (Moderately Improved), or 3 (Much Improved) to the the CGI-I question "Compared to the start of the study, how would you rate your nasal breathing now", will be defined as responders to treatment. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sino-Nasal Outcome Test (SNOT-22) | SNOT-22 is a 22-question survey designed to measure the physical, functional, and emotional consequences of rhinosinusitis. It contains questions regarding symptoms commonly associated with sinonasal disease. Subjects rate each question by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT-22 total score ranges from a minimum score of 0 to a maximum score of 110, with higher scores representing worse outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Severity (CGI-S); experimental arm | The CGI-Severity Scale from 1 to 7 (1 is "Not Obstructed at All", 7 is "Completely Obstructed") provides the severity of nasal obstruction as perceived from the patient. Comparison of CGI-S scores at 7 weeks with baseline will help identify subjects in the experimental arm who struggled with discontinuation of oxymetazoline. The investigators will report the number of subjects who report a worsening of their symptoms, as measured by a 2-point (2 categories) increase in CGI-S scale at 7 weeks as compared to CGI-S scale at baseline in the experimental arm only. |
Inclusion Criteria:
males and females ages 18 years or older
have a history of nasal obstruction
have failed a trial of topical steroids (that included at least 1 month of daily use)
ability to read, write, and understand English
either do not desire surgery or are poor surgical candidates due to medical comorbidities.
Patients who have had prior use of oxymetazoline or other nasal decongestants are eligible for the study but must have stopped usage 4 weeks prior to randomization.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nyssa Farrell, MD | Contact | 314-362-7509 | nyssa.farrell@wustl.edu | |
| Sara Kukuljan | Contact | 314-362-7563 | kukuljas@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nyssa F Farrell, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23282951 | Background | Scarupa MD, Kaliner MA. Nonallergic rhinitis, with a focus on vasomotor rhinitis: clinical importance, differential diagnosis, and effective treatment recommendations. World Allergy Organ J. 2009 Mar;2(3):20-5. doi: 10.1097/WOX.0b013e3181990aac. | |
| 20463822 | Background | Stewart M, Ferguson B, Fromer L. Epidemiology and burden of nasal congestion. Int J Gen Med. 2010 Apr 8;3:37-45. doi: 10.2147/ijgm.s8077. |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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| ID | Term |
|---|---|
| D010109 | Oxymetazoline |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Single-center, double-blinded, randomized, controlled trial conducted at Washington University School of Medicine
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The participant and the research team will be unaware of the participant's intervention assignment.
| Budesonide nasal spray | Drug | Intranasal corticosteroid that is available over-the-counter (OTC) |
|
|
| baseline, 2 weeks, and 4 weeks |
| Nasal Obstruction Symptom Evaluation (NOSE) | NOSE is a disease-specific survey designed to measure nasal obstruction. It consists of 5 questions, each rated on a scale of 0 to 4. The total score represents the sum of the raw scores multiplied by 5 and ranges from 0 to 100, with higher values indicating worse symptoms. A score of 30 is considered indicative of clinically significant nasal airway obstruction. | baseline, 2 weeks, 4 weeks |
| Clinical Global Impression of Severity (CGI-S) | The CGI-Severity Scale from 1 to 7 (1 is "Not Obstructed at All", 7 is "Completely Obstructed") provides the severity of nasal obstruction as perceived from the patient. Comparison of CGI-S scores at 4 weeks with baseline will help identify subjects that have experienced rebound congestion. The investigators will report the number of patients who report a worsening of their symptoms, as measured by a 1-point (1 category) increase in CGI-S scale at 4 weeks as compared to CGI-S scale at baseline. | baseline, week 4 |
| baseline, week 7 |
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| 20203244 | Background | Vaidyanathan S, Williamson P, Clearie K, Khan F, Lipworth B. Fluticasone reverses oxymetazoline-induced tachyphylaxis of response and rebound congestion. Am J Respir Crit Care Med. 2010 Jul 1;182(1):19-24. doi: 10.1164/rccm.200911-1701OC. Epub 2010 Mar 4. |
| 7515487 | Background | Graf P, Juto JE. Decongestion effect and rebound swelling of the nasal mucosa during 4-week use of oxymetazoline. ORL J Otorhinolaryngol Relat Spec. 1994 May-Jun;56(3):157-60. doi: 10.1159/000276633. |
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| 35712651 | Background | Kumar RS, Jain MK, Kushwaha JS, Patil S, Patil V, Ghatak S, Sanmukhani J, Mittal R. Efficacy and Safety of Fluticasone Furoate and Oxymetazoline Nasal Spray: A Novel First Fixed Dose Combination for the Management of Allergic Rhinitis with Nasal Congestion. J Asthma Allergy. 2022 Jun 10;15:783-792. doi: 10.2147/JAA.S357288. eCollection 2022. |
| Background | Matreja PS, Gupta V, Kaur J, Singh S. Efficacy of fluticasone and oxymetazoline as the treatment for allergic rhinitis. J Clin Diagn Res. 2012;6(1):85-88. |
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| 38195833 | Background | Juvekar MR, Vaidya GK, Majumder A, Pendharkar AD, Irudhayarajan A, Kundu A, Ramesh D, Kumar JD, Jagannatha B, Mathew J, Nikam MP, Mehta M, Chawla N, Hajare P, Gowda PGC, Murthy PVLN, Mathew SM, Damle MV, Kant C, Nair AB, Jaiswal A, Mehta RT. A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate-Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis. Clin Drug Investig. 2024 Feb;44(2):123-130. doi: 10.1007/s40261-023-01338-8. Epub 2024 Jan 9. |
| 6192384 | Background | Elwany SS, Stephanos WM. Rhinitis medicamentosa. An experimental histopathological and histochemical study. ORL J Otorhinolaryngol Relat Spec. 1983;45(4):187-94. doi: 10.1159/000275642. |
| 11374251 | Background | Elwany S, Abdel-Salaam S. Treatment of rhinitis medicamentosa with fluticasone propionate--an experimental study. Eur Arch Otorhinolaryngol. 2001 Mar;258(3):116-9. doi: 10.1007/s004050000309. |
| 17210334 | Background | Knipping S, Holzhausen HJ, Goetze G, Riederer A, Bloching MB. Rhinitis medicamentosa: electron microscopic changes of human nasal mucosa. Otolaryngol Head Neck Surg. 2007 Jan;136(1):57-61. doi: 10.1016/j.otohns.2006.08.025. |
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| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D011282 |
| Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |