Nasal Obstruction With Oxymetazoline and Corticosteroids

ConditionNasal Obstruction

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

males and females ages 18 years or older

have a history of nasal obstruction

have failed a trial of topical steroids (that included at least 1 month of daily use)

ability to read, write, and understand English

Disqualifiers

Any history of sinonasal mass/tumor

Any history of nasal polyps

a known history of chronic sinusitis

an allergy to oxymetazoline

Trial design

Design model

Parallel

Treatments tested in this trial

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)

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: budesonide + oxymetazoline,Experimental treatment 2 interventions

Group B: budesonideActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

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