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.

Brief Summary

Detailed Description

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.

Primary Outcomes

Secondary Outcomes

• Change from baseline in self-assessment of rhinorrhea after 24 hours, 72 and 120 hours post dose.(At 24 hours, 72 and 120 hours post dose)
• Change from baseline in self-assessment of nasal congestion at 24 and 120 hours post dose.(At 24 and 120 hours post dose.)
• Assessment of dryness of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.(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.(At 24 hours, 72 hours and 120 hours post dose.)
• Global evaluation assessments of study treatment by subjects at 72 hours post dose.(At 72 hours post dose.)
• Frequency and severity of AEs possibly, probably, or very likely related to the study drug during study treatment.(Through study completion, an average of 5 months.)
• Occurrence of serious AEs (SAEs).(Through study completion, an average of 5 months.)
• Occurence of AEs resulting in pre-mature withdrawal from the study.(Througout study completion, an average of 5 months.)
• Assessment of nasal crusting after 24 hours, 72 hours and 120 hours post dose.(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.(At 24 hours, 72 hours and 120 hours post dose)
• Frequency and severity of treatment emergent AEs reported during the study.(Through study completion, an average of 5 months.)