Nasal Congestion, Nasal ObstructionPhase 2NCT07582328
A Study to Learn More About How Well Oxymetazoline HCl 0.05% Nasal Gel Works and How Safe It Is in Healthy Adults
A Phase 2 study testing Oxymetazoline HCl 0.05% nasal gel in people with Nasal Congestion, Nasal Obstruction, run by Bayer at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Congestion, Nasal Obstruction
- What is being tested?
- Oxymetazoline HCl 0.05% nasal gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2026to 28 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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
- Being tested
- Oxymetazoline HCl 0.05% nasal gel, Placebo nasal gel
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymetazoline HCl 0.05% nasal gelDrug
Single dose; intranasally, once in each nostril.
Placebo nasal gelDrug
Single dose; intranasally, once in each nostril.
| Study group | Role | What they receive |
|---|---|---|
| Oxymetazoline HCl 0.05% nasal gel low dose | Experimental | Participants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril. Receives: 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. Receives: 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. Receives: Drug: Oxymetazoline HCl 0.05% nasal gel |
| Placebo nasal gel | Placebo comparator | Participants will self-administer placebo nasal gel, once in each nostril. Receives: Drug: Placebo nasal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 2 hours post-administration
Secondary outcomes (4)
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.
Measured: 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.
Measured: From baseline to 2 hours post-administration
Number of participants with adverse events (AEs), serious adverse events (SAEs), and Treatment Emergent AEs (TEAEs)
Measured: 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).
Measured: At 2 hours post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start20 Apr 2026
- Primary completion28 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Congestion, Nasal ObstructionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582328
- Sponsor's protocol ID
- 23157
- Status last verified
- Jun 2026
- First submitted
- 6 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07582328
- Acronym / sponsor ID
- 23157
- Conditions
- Nasal Congestion, Nasal Obstruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oxymetazoline HCl 0.05% nasal gel low dose | Experimental | Drug: Oxymetazoline HCl 0.05% nasal gelParticipants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril. |
| Oxymetazoline HCl 0.05% nasal gel intermediate dose | Experimental | Drug: Oxymetazoline HCl 0.05% nasal gelParticipants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril. |
| Oxymetazoline HCl 0.05% nasal gel high dose | Experimental | Drug: Oxymetazoline HCl 0.05% nasal gelParticipants will self-administer oxymetazoline HCl 0.05% nasal gel, once in each nostril. |
| Placebo nasal gel | Placebo comparator | Drug: Placebo nasal gelParticipants will self-administer placebo nasal gel, once in each nostril. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxymetazoline HCl 0.05% nasal gelSingle dose; intranasally, once in each nostril. | Drug | 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 gelSingle dose; intranasally, once in each nostril. | Drug | Placebo nasal gel |
Primary outcome
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.
4 secondary outcomes
Onset of action: Timed frequency using VAS
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
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
Time frame: At 2 hours post-administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No. Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxymetazoline HCl 0.05% nasal gel in people with Nasal Congestion, Nasal Obstruction, run by Bayer at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.