Nonallergic rhinitis, with a focus on vasomotor rhinitis: clinical importance, differential diagnosis, and effective treatment recommendations.
Mark D Scarupa, Michael A Kaliner
https://pubmed.ncbi.nlm.nih.gov/23282951Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06830109
Nasal Obstruction Randomized Trial With Oxymetazoline and Corticosteroids
Led by Washington University School of Medicine · Updated on 2025-09-11
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of combining oxymetazoline with intranasal corticosteroids for long-term treatment of chronic nasal obstruction that has not improved with standard care. Researchers believe that this combination may reduce nasal blockage more than corticosteroids alone without causing rhinitis medicamentosa, a rebound nasal congestion. Participants will be randomly assigned to one of two groups: one receiving a combination of oxymetazoline and budesonide nasal sprays, and the other receiving budesonide nasal spray alone. Both treatments involve applying two sprays in each nostril twice daily for a total of seven weeks. The nasal sprays will be mailed directly to the participants. Additionally, a small group of 10 participants will have nasal tissue biopsies taken at the start and between weeks 4 and 6. During the study, participants will complete surveys about their symptoms at baseline and at weeks 2, 4, 5, 6, and 7. Researchers will monitor how many respond to treatment by week 4 and assess nasal symptoms using specific tools like the Sino-Nasal Outcome Test and Nasal Obstruction Symptom Evaluation. Safety and overall condition will also be evaluated. The total participation period spans seven weeks with regular check-ins to track progress and side effects.
CONDITIONS
Brief Title
Nasal Obstruction With Oxymetazoline and Corticosteroids
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 years or older
- History of nasal obstruction
- Failed a trial of topical steroids with at least 1 month of daily use
- Ability to read, write, and understand English
- Do not desire surgery or are poor surgical candidates due to other health conditions
- Prior use of oxymetazoline or other nasal decongestants allowed if stopped 4 weeks before randomization
- Willingness to stop using other nasal sprays besides saline and oral decongestants during the study
You will not qualify if you...
- History of sinonasal mass or tumor
- History of nasal polyps
- Known chronic sinusitis
- Allergy to oxymetazoline
- Medical contraindications to oxymetazoline, such as pulmonary hypertension
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 7 weeks
Participants apply the intranasal spray, either oxymetazoline plus budesonide or budesonide alone, with two sprays in each nostril twice daily.
Questionnaires completed at baseline, Week 2, Week 4, Week 5, Week 6, and Week 7; a subset of participants may have nasal mucosal biopsies at baseline and between Weeks 4 and 6
Trial Site Locations
Total: 1 location
1
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
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Research Team
N
Nyssa Farrell, MD
S
Sara Kukuljan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Epidemiology and burden of nasal congestion.
Michael Stewart, Bj Ferguson, Len Fromer
https://pubmed.ncbi.nlm.nih.gov/20463822The effectiveness of oxymetazoline plus intranasal steroid in the treatment of chronic rhinitis: A randomised controlled trial.
Torpong Thongngarm, Paraya Assanasen, Panitan Pradubpongsa...
https://pubmed.ncbi.nlm.nih.gov/26994623The Role of Corticosteroid Nasal Irrigations in the Management of Chronic Rhinosinusitis: A State-of-the-Art Systematic Review.
Christian Calvo-Henriquez, Jaime Viera-Artiles, Miguel Rodriguez-Iglesias...
https://pubmed.ncbi.nlm.nih.gov/37240711Fluticasone reverses oxymetazoline-induced tachyphylaxis of response and rebound congestion.
Sriram Vaidyanathan, Peter Williamson, Karine Clearie...
https://pubmed.ncbi.nlm.nih.gov/20203244Decongestion effect and rebound swelling of the nasal mucosa during 4-week use of oxymetazoline.
P Graf, J E Juto
https://pubmed.ncbi.nlm.nih.gov/7515487An evaluation of nasal response following different treatment regimes of oxymetazoline with reference to rebound congestion.
S Morris, R Eccles, S J Martez...
https://pubmed.ncbi.nlm.nih.gov/9129752Efficacy and Safety of Fluticasone Furoate and Oxymetazoline Nasal Spray: A Novel First Fixed Dose Combination for the Management of Allergic Rhinitis with Nasal Congestion.
R S Kumar, Manish Kumar Jain, Jitendra Singh Kushwaha...
https://pubmed.ncbi.nlm.nih.gov/35712651Mometasone furoate nasal spray plus oxymetazoline nasal spray: short-term efficacy and safety in seasonal allergic rhinitis.
Eli O Meltzer, David I Bernstein, Bruce M Prenner...
https://pubmed.ncbi.nlm.nih.gov/23562197A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate-Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis.
Meenesh R Juvekar, Gauri Kapre Vaidya, Aniruddha Majumder...
https://pubmed.ncbi.nlm.nih.gov/38195833