NCT03480100

Non-interventional Study of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis

Non-interventional Study to Investigate the Efficacy and Tolerability of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Bitop AG · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: —

Summary

The goal of this non interventional study is to investigate the efficacy, tolerability and safety of the newly developed Ectoin Nasal Douche END01. Within the study, END01 will be used as concomitant therapy in addition to the use of a Xylometazoline-containing decongestant nasal spray. It will be investigated if the dosis of the used decongestant nasal spray might be reduced, the development of the disease might be positively influenced and/or the potentially occuring side effects (e.g. dryness of the nasal mucosa, sneezing) might be alleviated by using the Ectoin Nasal Douche as concomitant therapy.

Detailed description

The current non-interventional study aims to investigate the efficacy, tolerability and safety of a decongestant Xylometazoline-containing nasal spray in comparison to use of a decongestant Xylometazoline-containing nasal spray together with an Ectoin-containing nasal douche in patients with acute viral rhinosinusitis. 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 Nasal Douche	Application of Ectoin Nasal Douche (END01) in accordance with the instructions for use

Timeline

• Start date: 2017-11-27
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2018-03-29
• Last updated: 2018-07-11

Locations

1 site across 1 country: Germany