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Completed

NCT Number: NCT07582328

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

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.

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Key information

Conditions

Nasal Congestion, Nasal Obstruction Airway Obstruction Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cliantha Research

Mississauga, Ontario, L4W, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxymetazoline HCl 0.05% nasal gel

Drug

Single dose; intranasally, once in each nostril.

Placebo nasal gel

Drug

Single dose; intranasally, once in each nostril.

Primary outcomes

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

    Time frame: From baseline to 2 hours post-administration

    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.

Secondary outcomes

  1. Onset of action: Timed frequency using VAS

    Time frame: From baseline to 2 hours post-administration

    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.

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

    Time frame: From baseline to 2 hours post-administration

    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.

  3. 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

  4. Participant satisfaction/tolerability of study interventions

    Time frame: At 2 hours post-administration

    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).

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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