Clinical trial NCT03693976: Non-interventional Study With Ectoin Containing and/or Decongesting Nasal Spray in Patients With Rhinosinusitis
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Rhinosinusitis
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2018-10-03
Enrollment: 168
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged above 6 years diagnosed with acute viral rhinosinusitis

Brief 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.

Eligibility criteria: Inclusion Criteria:

* patients with acute viral rhinosinusitis
* presence of common cold symptoms

Exclusion Criteria:

* contraindications in accordance with instructions for use
* acute bacterial rhinosinusitis
* chronic rhinosinusitis

Primary outcomes:
measure: Physicians' assessment of change of intensity of rhinosinusitis symptoms
timeFrame: day 0 and day 7 and (if necessary, depending on study duration) and on day 14
Secondary outcomes:
measure: Physicians' assessment of general well-being of patients
timeFrame: day 0 and day 7 and day 14 (if necessary, depending on study duration)
measure: Patients' assessment of intensity of symptoms and their influence on quality of life
timeFrame: 7 to 14 days (depending on study duration)
measure: Investigators' and patients' assessment of efficacy of treatments
timeFrame: once on day 7 or day 14 (depending on study duration)
measure: Assessment of the tolerability of treatments
timeFrame: once on day 7 or once on day 14 of treatment (depending on study duration)
measure: Incidence of adverse events/serious adverse events
timeFrame: 7 to 14 days (depending on study duration)
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: bitop AG
Study officials:
affiliation: CSO
name: Andreas Bilstein, Dr.
role: STUDY_DIRECTOR
References:
citation: Werkhauser N, Bilstein A, Mahlstedt K, Sonnemann U. Observational study investigating Ectoin(R) Rhinitis Nasal Spray as natural treatment option of acute rhinosinusitis compared to treatment with Xylometazoline. Eur Arch Otorhinolaryngol. 2022 Mar;279(3):1371-1381. doi: 10.1007/s00405-021-06916-0. Epub 2021 Jun 4.