Recruiting

Nasal congestion, Nasal Obstruction

Bayer Identifier:

23157

ClinicalTrials.gov Identifier:

NCT07582328

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 65 Years

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.

Trial summary

Enrollment Goal

120

Trial Dates

April 2026 - August 2026

Phase

Phase 2

Could I Receive a placebo

Yes

Products

Afrin(Oxymetazoline Hydrochloride, BAYP004987)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Recruiting	Cliantha Research	Mississauga, L4W, Canada

Primary Outcome

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.
Time Frame:
From baseline to 2 hours post-administration

Secondary Outcome

Onset of action: Timed frequency using VAS
VAS (0-100 mm): 0 being completely clear and 100 being completely obstructed. VAS scoring will be assessed at baseline and from 10 seconds post-study intervention administration to establish the earliest onset of action.
Time Frame:
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
The participant’s PNIF will be measured with a device coupled to the anterior region of the nose through a mask connected to a plastic cylinder through which the forced inspired air passes. Participants will be trained on the performance of PNIF prior to dosing. Each participant will undergo 3 maneuvers at each specified timepoint, and all 3 attempts will be documented. Only the highest value of the 3 maneuvers will be used for assessment of endpoint analysis.
Time Frame:
From baseline to 2 hours post-administration
Number of participants with adverse events (AEs), serious adverse events (SAEs), and Treatment Emergent AEs (TEAEs)
Time Frame:
From baseline to 2 hours post-administration
Participant satisfaction/tolerability of study interventions
Participant satisfaction/tolerability will be evaluated by means of a five-point verbal rating scale to responses to a questionnaire (0 = very good, 1 = good, 2 = satisfactory, 3 = minimal, 4 = none).
Time Frame:
At 2 hours post-administration

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

N/A

Assignment

Parallel Assignment

Trial Arms

Additional Information

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.