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

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.

Study Overview

• Status: Completed
• Conditions: Acute Rhinosinusitis
• Intervention / Treatment: Device: Ectoin Rhinosinusitis Nasal Spray; Drug: Xylometazoline Nasal Spray

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.

• Study Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

• Germany
  • Dortmund, Germany, 44263
    • bitop AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged above 6 years diagnosed with acute viral rhinosinusitis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ectoin Rhinosinusitis Nasal Spray; application of 1-2 sprays of SNS01 into each nostril several times a day	Device: Ectoin Rhinosinusitis Nasal Spray; Application of Ectoin Nasal Spray (SNS01) in accordance with the instructions for use; Other Names: SNS01
Xylometazoline nasal spray; 1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day	Drug: Xylometazoline Nasal Spray; Application of Xylometazoline Nasal Spray in accordance with the instructions for use; Other Names: NasenSpray-ratiopharm Erwachsene (adults)
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	Device: Ectoin Rhinosinusitis Nasal Spray; Application of Ectoin Nasal Spray (SNS01) in accordance with the instructions for use; Other Names: SNS01; Drug: Xylometazoline Nasal Spray; Application of Xylometazoline Nasal Spray in accordance with the instructions for use; Other Names: NasenSpray-ratiopharm Erwachsene (adults)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physicians' assessment of change of intensity of rhinosinusitis symptoms	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.	day 0 and day 7 and (if necessary, depending on study duration) and on day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physicians' assessment of general well-being of patients	The investigators will assess the well-being of patients using a 4-point scale (good condition to strong illness).	day 0 and day 7 and day 14 (if necessary, depending on study duration)
Patients' assessment of intensity of symptoms and their influence on quality of life	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).	7 to 14 days (depending on study duration)
Investigators' and patients' assessment of efficacy of treatments	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).	once on day 7 or day 14 (depending on study duration)
Assessment of the tolerability of treatments	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).	once on day 7 or once on day 14 of treatment (depending on study duration)
Incidence of adverse events/serious adverse events	All occurring adverse events/serious adverse events will be documented during the entire study period.	7 to 14 days (depending on study duration)

Collaborators and Investigators

• Sponsor: Bitop AG
• Investigators: Study Director: Andreas Bilstein, Dr., CSO

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Respiratory System Agents; Vasoconstrictor Agents; Nasal Decongestants; Xylometazoline
• Other Study ID Numbers: btph-010-2018-SNS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No