NCT03693976

Non-interventional Study With Ectoin Containing and/or Decongesting Nasal Spray in Patients With Rhinosinusitis

Non-interventional Study in Patients With Acute Rhinosinusitis to Study Efficacy and Tolerability of Ectoin Rhinosinusitis Nasal Spray, a Xylometazoline-containing Nasal Spray or a Combination of Both.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 168 (actual)
• Sponsor: Bitop AG · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The goal of this non-interventional study is to investigate the efficacy and tolerability of an Ectoin containing Rhinosinusitis Nasal Spray (SNS01). Within the study, SNS01 will be used either alone as monotherapy or as concomitant therapy in addition to the use of a Xylometazoline-containing decongestant nasal spray. A control group will use a Xylometazoline-containing decongestant nasal spray as monotherapy. It will be investigated if the dose of the used decongestant nasal spray might be reduced, the development of the disease might be positively influenced and/or the potentially occurring side effects (e.g. dryness of the nasal mucosa, sneezing) might be alleviated by using the Ectoin containing Rhinosinusitis Nasal Spray as concomitant therapy.

Detailed description

The current non-interventional study aims to investigate the efficacy and tolerability of Ectoin containing Rhinosinusitis Nasal Spray (SNS01) in patients with acute rhinosinusitis. Patients can chose one of three treatment options: a) Ectoin containing Rhinosinusitis Nasal Spray (SNS01), b) decongestant Xylometazoline-containing nasal spray or c) Ectoin containing Rhinosinusitis Nasal Spray (SNS01) and a decongestant Xylometazoline-containing nasal spray. Efficacy will be studied by documentation of the following symptoms: * oedema, redness (assessed by rhinoscopy) * nasal obstruction, nasal secretion, headache/face pain, loss of sense of smell/taste * sore throat, cough In parallel, participating patients will document their symptoms and the their quality of life over the entire study duration in patient diaries. Patients of both genders aged 6 years and above can take part in the study if diagnosed with acute viral rhinosinusitis. The assignment of a patient to a particular treatment is not decided in advance but falls within current practice, and is clearly separated from the decision to include the patient into the study. Study therapy will be applied in accordance with the respective instructions for use. Study duration is 7-14 days, depending on the improvement of symptoms. At the end of the study, both the investigators and the patients are asked to judge the efficacy and tolerability of the treatments.

Conditions

• Acute Rhinosinusitis

Interventions

Type	Name	Description
DRUG	Xylometazoline Nasal Spray	Application of Xylometazoline Nasal Spray in accordance with the instructions for use
DEVICE	Ectoin Rhinosinusitis Nasal Spray	Application of Ectoin Nasal Spray (SNS01) in accordance with the instructions for use

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-04-15
• Completion: 2019-04-15
• First posted: 2018-10-03
• Last updated: 2019-07-10

Locations

1 site across 1 country: Germany