Nasal Obstruction With Oxymetazoline and Corticosteroids

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06830109
Phase
PHASE2
Status
Recruiting
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Conditions

  • Nasal Obstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
Sep 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: budesonide + oxymetazoline,
    alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC).
  • Active Comparator: budesonide
    intranasal corticosteroid that is available OTC.

Primary Outcome Measure

Rate of Responders [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington UniversitySt LouisMissouri63110
Sara Kukuljan
[email protected]
314-362-7563
Lucas Cruz, BA
[email protected]
314-362-0549

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By research site
Washington University· St Louis, MO

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