Acute Rhinosinusitis Clinical Trial
Official title:
Non-interventional Study to Investigate the Efficacy and Tolerability of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis
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.
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.
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