Nasal Obstruction With Oxymetazoline and Corticosteroids

Официальное название

Nasal Obstruction Randomized Trial With Oxymetazoline and Corticosteroids

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Oxymetazoline Nasal Spray
  Intra-nasal alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC)
• Препарат Budesonide nasal spray
  Intranasal corticosteroid that is available over-the-counter (OTC)

Первичные конечные точки

• Rate of Responders [Срок оценки: 4 weeks]

Вторичные конечные точки (3)

• Sino-Nasal Outcome Test (SNOT-22) [Срок оценки: baseline, 2 weeks, and 4 weeks]
• Nasal Obstruction Symptom Evaluation (NOSE) [Срок оценки: baseline, 2 weeks, 4 weeks]
• Clinical Global Impression of Severity (CGI-S) [Срок оценки: baseline, week 4]

Критерии участия

Критерии включения

• 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.

• Must be willing to stop using any other nasal sprays, besides saline, and oral decongestants.

Критерии исключения

• Any history of sinonasal mass/tumor
• Any history of nasal polyps
• a known history of chronic sinusitis
• an allergy to oxymetazoline
• or who have any medical contraindication to oxymetazoline use, such as pulmonary hypertension.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Washington University — St Louis

Публикации

• 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. PMID 23282951
• 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. PMID 20463822
• Thongngarm T, Assanasen P, Pradubpongsa P, Tantilipikorn P. The effectiveness of oxymetazoline plus intranasal steroid in the treatment of chronic rhinitis: A randomised controlled trial. Asian Pac J Allergy Immunol. 2016 Mar;34(1):30-7. doi: 10.12932/AP0649.34.1.2016. PMID 26994623
• Calvo-Henriquez C, Viera-Artiles J, Rodriguez-Iglesias M, Rodriguez-Rivas P, Maniaci A, Yanez MM, Martinez-Capoccioni G, Alobid I. The Role of Corticosteroid Nasal Irrigations in the Management of Chronic Rhinosinusitis: A State-of-the-Art Systematic Review. J Clin Med. 2023 May 22;12(10):3605. doi: 10.3390/jcm12103605. PMID 37240711
• 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. PMID 20203244
• 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. PMID 7515487
• Morris S, Eccles R, Martez SJ, Riker DK, Witek TJ. An evaluation of nasal response following different treatment regimes of oxymetazoline with reference to rebound congestion. Am J Rhinol. 1997 Mar-Apr;11(2):109-15. doi: 10.2500/105065897782537197. PMID 9129752
• 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. PMID 35712651

Идентификаторы

NCT: NCT06830109 · 202406175

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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