Nasal Congestion, Nasal Obstruction
Conditions
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.
Interventions
DRUGOxymetazoline HCl 0.05% nasal gel
Single dose; intranasally, once in each nostril.
Single dose; intranasally, once in each nostril.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change from baseline (CFB) in nasal congestion considered by timepoint and difference over 2 hours post-treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Onset of action: Timed frequency using VAS | 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. |
| 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 | 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. |
| 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 | 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). |
Countries
Canada
Outcome results
None listed