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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Single dose; intranasally, once in each nostril.
Single dose; intranasally, once in each nostril.
Cliantha Research
Mississauga, Ontario, Canada
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
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
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