Combination treatment for chronic nasal obstruction
Nasal Obstruction Randomized Trial With Oxymetazoline and Corticosteroids
This study is testing if a combination of a nasal spray and steroids can help people with chronic nasal obstruction who haven't found relief with regular treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06830109 on ClinicalTrials.gov |
What this trial studies
This study examines the efficacy and safety of combining oxymetazoline with intranasal corticosteroids for managing chronic nasal obstruction that does not respond to standard treatments. Participants will be randomized to receive either the combination treatment or corticosteroids alone over a 7-week period. They will apply the nasal spray twice daily and complete questionnaires to assess their symptoms. A subset of participants will also undergo nasal mucosal biopsies to evaluate treatment effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of nasal obstruction who have not responded to topical steroids.
Not a fit: Patients with a history of sinonasal mass, nasal polyps, or chronic sinusitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for patients suffering from chronic nasal obstruction.
How similar studies have performed: Other studies have shown promise with similar combination treatments, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. males and females ages 18 years or older 2. have a history of nasal obstruction 3. have failed a trial of topical steroids (that included at least 1 month of daily use) 4. ability to read, write, and understand English 5. either do not desire surgery or are poor surgical candidates due to medical comorbidities. 6. 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. 1. Must be willing to stop using any other nasal sprays, besides saline, and oral decongestants. Exclusion Criteria: 1. Any history of sinonasal mass/tumor 2. Any history of nasal polyps 3. a known history of chronic sinusitis 4. an allergy to oxymetazoline 5. or who have any medical contraindication to oxymetazoline use, such as pulmonary hypertension.
Where this trial is running
St Louis, Missouri
- Washington University — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Nyssa F Farrell, MD — Washington University School of Medicine
- Study coordinator: Nyssa Farrell, MD
- Email: nyssa.farrell@wustl.edu
- Phone: 314-362-7509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.