A Study to Learn More About How Well Oxymetazoline HCl 0.05% Nasal Gel Works and How Safe It Is in Healthy Adults

NCT07582328 | Completed Phase 2

• 1 other identifier: 23157
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Nasal congestion (a "stuffy nose") is a common symptom of colds and seasonal or year-round allergies. It happens when the tiny blood vessels and tissues inside the nose swell and leak fluid, producing more mucus. That swelling and extra fluid make the nasal passages narrower, which can make it hard to breathe through the nose, sleep, or do daily activities. Oxymetazoline works on alpha-adrenergic receptors in the tiny blood vessels inside the nose. When these receptors are activated, the blood vessels tighten (constrict), which helps reduce swelling and open the nasal passages. The study drug, oxymetazoline hydrochloride (HCl) 0.05% nasal gel, is a gel form of a well-known decongestant that is typically available as a nasal spray. The gel may remain in contact with the nose longer than a spray and could feel different to use. The main purpose of this study is to learn how well a single dose of oxymetazoline HCl 0.05% nasal gel relieves nasal congestion within the first 2 hours after dosing using two different measures. The study will also look at safety and how well people tolerate the gel.

Conditions

Nasal Congestion, Nasal Obstruction

Outcome Measures

Primary Outcomes (1)

• The change from baseline (CFB) in nasal congestion considered by timepoint and difference over 2 hours post-treatment

  Subjective feeling of nasal congestion will be evaluated by the 100 mm Visual Analog Score (VAS) (0-100 mm): 0 being completely clear and 100 being completely obstructed.

  From baseline to 2 hours post-administration

Secondary Outcomes (4)

• Onset of action: Timed frequency using VAS

  From baseline to 2 hours post-administration

• The change from baseline in Peak Nasal Inspiratory Flow (PNIF) measurement via nasal peak flow by timepoint and averaged over 2 hours post-treatment

  From baseline to 2 hours post-administration

• Number of participants with adverse events (AEs), serious adverse events (SAEs), and Treatment Emergent AEs (TEAEs)

  From baseline to 2 hours post-administration

• Participant satisfaction/tolerability of study interventions

  At 2 hours post-administration

Study Arms (4)

Oxymetazoline HCl 0.05% nasal gel low dose

EXPERIMENTAL

Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.

Drug: Oxymetazoline HCl 0.05% nasal gel

Oxymetazoline HCl 0.05% nasal gel intermediate dose

EXPERIMENTAL

Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.

Drug: Oxymetazoline HCl 0.05% nasal gel

Oxymetazoline HCl 0.05% nasal gel high dose

EXPERIMENTAL

Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril.

Drug: Oxymetazoline HCl 0.05% nasal gel

Placebo nasal gel

PLACEBO COMPARATOR

Participants will self-administer placebo nasal gel, once in each nostril.

Drug: Placebo nasal gel

Interventions

Oxymetazoline HCl 0.05% nasal gel DRUG

Single dose; intranasally, once in each nostril.

Oxymetazoline HCl 0.05% nasal gel high dose; Oxymetazoline HCl 0.05% nasal gel intermediate dose; Oxymetazoline HCl 0.05% nasal gel low dose

Placebo nasal gel DRUG

Single dose; intranasally, once in each nostril.

Placebo nasal gel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Cliantha Research

Mississauga, Ontario, L4W, Canada

Location

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Oxymetazoline

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: April 20, 2026
• Primary Completion: May 28, 2026
• Study Completion: May 28, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)