Acute Rhinosinusitis Clinical Trial
Official title:
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.
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.
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.
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