Clinical trial NCT06830109: Nasal Obstruction With Oxymetazoline and Corticosteroids
Official title: Nasal Obstruction Randomized Trial With Oxymetazoline and Corticosteroids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Nasal Obstruction
Keywords: Oxymetazoline
Corticosteroids
Chronic rhinitis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, double-blinded, randomized, controlled trial conducted at Washington University School of Medicine
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Rate of Responders
timeFrame: 4 weeks
Secondary outcomes:
measure: Sino-Nasal Outcome Test (SNOT-22)
timeFrame: baseline, 2 weeks, and 4 weeks
measure: Nasal Obstruction Symptom Evaluation (NOSE)
timeFrame: baseline, 2 weeks, 4 weeks
measure: Clinical Global Impression of Severity (CGI-S)
timeFrame: baseline, week 4
Other outcomes:
measure: Clinical Global Impression of Severity (CGI-S); experimental arm
timeFrame: baseline, week 7
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Nyssa F Farrell, MD
role: PRINCIPAL_INVESTIGATOR
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