As the medical device is CE marked, the objective of this study is to provide performance and
      safety data on SULFEX 13081.22 nasal spray as close as possible to the routine care.

Pilot Study to Assess Performance and Safety of SULFEX 13081.22 Nasal Spray in Patients With Dry or Irritated Nose

Dry Nose

Nose Irritation

Every day, people breathe large amounts of air which contain all kinds of particles. Nasal
      cavities are the first site of airway protection against airborne particles. The mucociliary
      apparatus (a layer of tiny moving hairs and mucus which covers the mucous membrane inside the
      nose) is the first line of defence of the upper airways and helps to eliminate these
      particles. If this defence mechanism is altered, it may cause nasosinusal damage or
      irritation and be unable to protect the respiratory system.

      Moreover, external factors such as pollution or dry air may affect the function of the nose.
      The same is true for chronic and/or recurrent infections. These various factors can cause
      irritation or dryness of the nasal mucosa, often causing inflammation with feelings of
      congestion, discomfort or burning of the nasal mucosa, sometimes with bleeding or painful
      crusting.

      SULFEX 13081.22 is a nasal spray, CE marked and commercialized since 2014. SULFEX spray
      soothes, restores and provides long-lasting/intense hydration of uncomfortable, painful or
      sore nasal mucosa caused by excessive dryness. It also contributes towards cell regeneration
      for faster healing and optimum relief and protects against new external attacks.The
      anti-reflux valve system prevents any contamination of the solution, even after the bottle
      has been opened, which means the formula remains 100% aseptic.

      As the medical device is CE marked, the objective of this study is to provide performance and
      safety data on SULFEX 13081.22 nasal spray as close as possible to the routine care.

SULFEX 13081.22

Severity of the following nasal symptoms will be compared before and 6 days after spray use on a 7-point scale basis.
Nasal irritation
Nasal dryness Performance on Irritation and Dryness will be verified if there is a decrease of at least 0.5 point on at least one of the two symptom scores between Day 0 and Day 6. This item is scaled from 0 to 3, with 0.5 increments and 3 being the worst value.

To collect safety data on the SULFEX 13081.22 nasal spray after 6 days of use (with at least 1 spray use a day). Proportion of patients with at least one adverse device effect occurred between the first and the last spray use.

To assess the performance of the SULFEX 13081.22 nasal spray, on the following nasal symptoms, after 6 days of use (with at least 1 spray use a day).
Nasal crusting
Nasal bleeding
Nasal itching
Nasal burning
Nasal obstruction
Nasal pain
Nasal discomfort
Sneezing
Reduced sense of smell
External nasal redness
External nasal swelling Performance on a particular symptom will be verified if there is a decrease of at least 0.5 point in the symptom score between Day 0 and Day 6.
This item is scaled from 0 to 3, with 0.5 increments and 3 being the worst value.

To assess nasal symptoms relief/reduction each day, from Day 0 to Day 6. Assessment of nasal symptoms mean scores at D0 / D1 / D2 / D3 / D4 / D5 and D6.
This item is scaled from 0 to 3, with 0.5 increments and 3 being the worst value.

To assess onset of relief (immediate or semi-immediate relief). Proportion of patients with immediate or semi-immediate relief.
An immediate relief is defined as a nasal symptom improvement at 1 min or 10 min after the 1st spray use of the day. A semi-immediate relief is defined as a nasal symptom improvement at 1 hour after the 1st spray use of the day.

To assess duration of relief (long lasting). This item is scaled from 0 to 3, with 0.5 increments and 3 being the worst value.

To assess the day at which patients regained their previous nasal state of well-being (feeling of well-being). Day at which the patient regained his/her previous nasal state of well-being (feeling of well-being) + proportion of patients with an overall relief.
This item is scaled from 0 to 3, with 0.5 increments and 3 being the worst value.

To assess the medical device usability. assessment of the proportion of patients that would agree with each usability criteria on a 5-point scale basis.
This item is scaled from 1 to 5, with 1 increments and 1 being the worst value.

To assess product attributes of the medical device. Assessment of proportion of patients that would agree with each product attribute on a 5-point scale basis.
This item is scaled from 1 to 5, with 1 increments and 1 being the worst value.

To assess patient satisfaction regarding the medical device. Assessment of Proportion of patients satisfied with the medical device use on a 5-point scale basis.
Proportion of patient liking the medical device on a 5-point scale basis + aspect that is most liked and disliked about the medical device.
Proportion of patients wishing to continue using the medical device on a 5-point scale basis.
Proportion of patients that would recommend the medical device on a 5-point scale basis.
This item is scaled from 1 to 5, with 1 increments and 1 being the worst value.

Patients with dry or irritated nose treated with SULFEX 13081.22 nasal spray for 6 days (with at least 1 spray use a day).

Pilot Study to Assess Performance and Safety of SULFEX 13081.22 Nasal Spray in Patients With Dry or Irritated Nose

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status