A Phase 2 interventional study of Oxymetazoline Nasal Spray and Budesonide nasal spray in Nasal Obstruction, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment
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.
108 studies on the registry are indexed under Nasal Obstruction; 27 are open to participants now.
This study's planned enrollment of 80 is above the median of 52 across 80 interventional studies indexed under Nasal Obstruction.
Browse Nasal Obstruction studies →Washington University School of Medicine is the lead sponsor of 1,764 studies on the registry; 270 are open to participants now.
Of its 325 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC).
Drug: Oxymetazoline Nasal Spray · Drug: Budesonide nasal spray
intranasal corticosteroid that is available OTC.
Drug: Budesonide nasal spray
Intra-nasal alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC)
Also known as: Afrin (commercial name for oxymetazoline hydrochloride)
Intranasal corticosteroid that is available over-the-counter (OTC)
Also known as: Rhinocort (commercial name for budesonide)
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.
Time frame: 4 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, week 4
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.
Time frame: baseline, week 7
Plan to share: No
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