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

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Abstract

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.

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.

Dates

Last Verified:	10/31/2018
First Submitted:	09/30/2018
Estimated Enrollment Submitted:	09/30/2018
First Posted:	10/02/2018
Last Update Submitted:	07/08/2019
Last Update Posted:	07/09/2019
Actual Study Start Date:	09/30/2018
Estimated Primary Completion Date:	04/14/2019
Estimated Study Completion Date:	04/14/2019

Condition or disease

Acute Rhinosinusitis

Intervention/treatment

Drug: Xylometazoline Nasal Spray

Device: Ectoin Rhinosinusitis Nasal Spray

Phase

Arm Groups

Arm	Intervention/treatment
Ectoin Rhinosinusitis Nasal Spray application of 1-2 sprays of SNS01 into each nostril several times a day
Xylometazoline nasal spray 1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day
Xylometazoline + Ectoin Nasal Spray Xylometazoline: 1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day, Ectoin Nasal Spray (SNS01): 1-2 sprays per nostril several times a day

Eligibility Criteria

Ages Eligible for Study	6 Years To 6 Years
Sexes Eligible for Study	All
Sampling method	Non-Probability Sample
Accepts Healthy Volunteers	Yes
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

Outcome

Primary Outcome Measures

1. Physicians' assessment of change of intensity of rhinosinusitis symptoms [day 0 and day 7 and (if necessary, depending on study duration) and on day 14]

Both on day 0 and on day 7 (and, if necessary, depending on study duration, on day 14), the physicians will assess rhinosinusitis symptoms oedema, redness of the nose, nasal obstruction, nasal secretion, facial pain/headache, smell/taste dysfunction and the concomitant symptoms dryness of the nasal mucosa and sore throat. Assessment will be carried out based on a 5-point scale (0=none to 4=very strong). Change of symptoms will be assessed comparing symptom scores on day 7 (or day 14, if applicable) to day 0. The investigators will use rhinoscopy, physical examination and interview of the patients for the assessments.

Secondary Outcome Measures

1. Physicians' assessment of general well-being of patients [day 0 and day 7 and day 14 (if necessary, depending on study duration)]

The investigators will assess the well-being of patients using a 4-point scale (good condition to strong illness).

2. Patients' assessment of intensity of symptoms and their influence on quality of life [7 to 14 days (depending on study duration)]

Patients will document their rhinosinusitis symptoms and their influence on quality of life (22 parameters in accordance with the "sino-nasal outcome test-22 questionnaire") and the additional symptom "dry nose". They will document their judgement daily in a patient diary using a 6-point scale (0=no problem to 5=as bad as possible).

3. Investigators' and patients' assessment of efficacy of treatments [once on day 7 or day 14 (depending on study duration)]

At the end of the study, both investigators and patients will judge the overall efficacy of the treatment based on a 6-point scale (1=very good to 6=unsatisfactory).

4. Assessment of the tolerability of treatments [once on day 7 or once on day 14 of treatment (depending on study duration)]

Both investigators and patients will judge the tolerability of the treatments at the end of the study. Both investigators and patients will judge the tolerability based on a 6 point scale (1=very good to 6 = unsatisfactory).

5. Incidence of adverse events/serious adverse events [7 to 14 days (depending on study duration)]

All occurring adverse events/serious adverse events will be documented during the entire study period.

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

Keywords

sinusitis

pharyngitis

facial pain

headache

erythema

cough