Oxymetazoline 0.05% nasal gel for sudden nasal congestion in healthy adults

A Placebo-Controlled, Double-Blind, Dose-Finding Study to Evaluate Efficacy and Safety of 0.05% Oxymetazoline HCl Nasal Gel in Healthy Adults, 18-65 Years of Age

This will test whether a single dose of oxymetazoline 0.05% nasal gel quickly relieves nasal congestion in otherwise healthy adults.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Bayer (Industry-sponsored)
• Locations: 1 site (Mississauga, Ontario)
• Trial ID: NCT07582328 on ClinicalTrials.gov

What this trial studies

This Phase 2, randomized interventional trial compares a single dose of oxymetazoline HCl 0.05% nasal gel to placebo in adults aged 18–65 who report acute nasal congestion from a cold or allergies. Participants must meet a symptom severity threshold on a visual analog scale and undergo medical and nasal examinations before dosing. The primary outcome is relief of nasal congestion within the first two hours after a single dose, with safety monitoring for adverse effects. The study is sponsored by Bayer and conducted at a clinical site in Mississauga, Ontario.

Who should consider this trial

Good fit: Ideal candidates are generally healthy adults 18–65 with recent-onset nasal congestion from an upper respiratory infection or allergies who meet the study's symptom score requirements and pass screening exams.

Not a fit: Patients with chronic nasal congestion or excluded conditions such as uncontrolled cardiovascular disease, narrow-angle glaucoma, significant systemic illnesses, or prostate enlargement are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the gel formulation could provide faster or longer nasal relief than existing sprays by remaining in contact with nasal tissue longer.

How similar studies have performed: Oxymetazoline sprays are a well-established, effective decongestant, so the active drug's mechanism is proven though the gel formulation is a newer delivery form.

Eligibility criteria

Inclusion Criteria:

* Male and female participants, age between 18 to 65 years at the time of signing the informed consent.
* Participants in good general health per medical evaluation (medical, allergy, and social history; physical and nasal examinations).
* Participants who self-report acute nasal congestion as symptoms of an acute upper respiratory tract infection or allergies and a VAS score meeting the study-defined threshold.
* Participants should abstain from use of nicotine products or any forms of nicotine replacement therapy, and consuming alcohol at least 12 hours prior to the study.

Exclusion Criteria:

* Any of the following conditions: severe or unstable or uncontrolled cardiovascular disease, cerebral or coronary insufficiency, Raynaud's Syndrome, thromboangitis obliterans, scleroderma, Sjögren's syndrome, renal or hepatic impairment, thyroid disease, diabetes, chronic congestion, COVID, influenza and enlarged prostate.
* Participants with narrow angle glaucoma.
* History of nasal surgery or nasal abnormalities.
* Participants with history of frequent nosebleeds or with rhinitis medicamentosa.
* Females who are pregnant, breast feeding, or planning a pregnancy.
* Participants with inflammation of the skin and mucosa of nasal vestibule and encrustation (rhinitis sicca).
* Presence of acute or chronic illnesses that may affect sensory function.
* A history of drug or alcohol abuse within 12 months prior to the study visit.
* A positive drug /alcohol/CO test.
* History of sensitivity/ anaphylaxis to any of the study medications.

Where this trial is running

Mississauga, Ontario

• Cliantha Research — Mississauga, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Bayer Clinical Trials Contact

Conditions Nasal Congestion; Nasal Obstruction