An observer-blind, multi-centre, randomized, parallel-group study to compare the efficacy and safety of two formulations of xylometazoline/dexpanthenol nasal spray for the treatment of nasal congestion caused by an acute upper respiratory tract infection in adults.
This observer-blind multi-center, randomized, parallel-group study in adults is designed to demonstrate non-inferiority between two formulations of xylometazoline/dexpanthenol nasal sprays in terms of efficacy and safety, when the products are used according to labeled instructions in a home based setting. Subjects suffering from nasal congestion caused by acute Upper Respiratory Tract Infection (URTI) and seeking medical counselling, will after screening and baseline assessment of nasal congestion, be randomized, and perform additional baseline subjective assessments of nasal rhinorrhea (scores on categorical scales). The Investigator will perform subjective baseline assessments of crust formation and dryness, redness and edema of nasal mucosa (anterior rhinoscopy using nasal speculum or otoscope). After the baseline assessments, the subjects will receive xylometazoline/dexpanthenol nasal spray or marketed reference nasal spray according to randomization.The first dose will be taken at the site under supervision. The study nurse will schedule visits for 24 hours, 72 hours and 120 hours after this first dose and the subjects will be released for home based treatment. At the 72-hour visit, the primary and secondary efficacy endpoints will be assessed by the subject and the Investigator, safety will be followed up and subjects will also evaluate the treatment in a global assessment. At the 24-hour visit and at the final visit, after a maximum of 5 full days (120 hours) of treatment, all secondary endpoints will be assessed and safety will be followed up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
140
Xylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.
Xylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.
Railways clinical hospital n.a.Semashko at Lublino station JSC "RZD"
Moscow, Russia
City Polyclinic #2
Moscow, Russia
First Moscow State Medical University n. a. I. M. Sechenov
Moscow, Russia
"Scientific and Research centre Eco-safety" Limited Liability Company
Saint Petersburg, Russia
Change from baseline in self-assessment of nasal congestion after 72 hours of treatment.
Change from baseline in self-assessment of nasal congestion after 72 hours of treatment.
Time frame: After 72 hours of treatment.
Change from baseline in self-assessment of nasal congestion at 24 and 120 hours post dose.
Change from baseline in self-assessment of nasal congestion at 24 and 120 hours post dose.
Time frame: At 24 and 120 hours post dose.
Change from baseline in self-assessment of rhinorrhea after 24 hours, 72 and 120 hours post dose.
Change from baseline in self-assessment of rhinorrhea after 24 hours, 72 and 120 hours post dose.
Time frame: At 24 hours, 72 and 120 hours post dose
Assessment of nasal crusting after 24 hours, 72 hours and 120 hours post dose.
Assessment of nasal crusting after 24 hours, 72 hours and 120 hours post dose.
Time frame: At 24 hours, 72 hours and 120 hours post dose.
Assessment of dryness of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Assessment of dryness of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Time frame: At 24 hours, 72 hours and 120 hours post dose.
Assessment of redness of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Assessment of redness of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Time frame: At 24 hours, 72 hours and 120 hours post dose.
Assessment of edema of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
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The First St. Petersburg state medical University n.a. Acad. I. P. Pavlov
Saint Petersburg, Russia
Assessment of edema of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Time frame: At 24 hours, 72 hours and 120 hours post dose
Global evaluation assessments of study treatment by subjects at 72 hours post dose.
Global evaluation assessments of study treatment by subjects at 72 hours post dose.
Time frame: At 72 hours post dose.
Frequency and severity of treatment emergent AEs reported during the study.
Each treatment emergent AE reported during the trial and it´s severity will be tabulated in a list, capturing frequency and severity of all treatment emergent AEs occuring during the trial.
Time frame: Through study completion, an average of 5 months.
Frequency and severity of AEs possibly, probably, or very likely related to the study drug during study treatment.
Each AE which has been ranked as possibly, probably, or very likely related to the study drug during study treatment will be tabulated in a list capturing frequency and severity of all these AEs occuring during the trial.
Time frame: Through study completion, an average of 5 months.
Occurrence of serious AEs (SAEs).
Occurrence of serious AEs (SAEs), will be tabulated in a list.
Time frame: Through study completion, an average of 5 months.
Occurence of AEs resulting in pre-mature withdrawal from the study.
Occurence of AEs resulting in pre-mature withdrawal from the study will be tabulated in a list.
Time frame: Througout study completion, an average of 5 months.