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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

May 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Physicians' assessment of change of intensity of rhinosinusitis symptoms[ Time Frame: 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Physicians' assessment of general well-being of patients[ Time Frame: 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).
Patients' assessment of intensity of symptoms and their influence on quality of life[ Time Frame: 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).
Assessment of the efficacy of treatments[ Time Frame: 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).
Assessment of the tolerability of treatments[ Time Frame: once on day 7 or day 14 (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).
Incidence of adverse events/serious adverse events[ Time Frame: 7 to 14 days (depending on study duration) ]
All occurring adverse events/serious adverse events will be documented during the entire study period.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Drug: Xylometazoline Nasal Spray
Application of Xylometazoline Nasal Spray in accordance with the instructions for use
Device: Ectoin Rhinosinusitis Nasal Spray
Application of Ectoin Nasal Spray (SNS01) in accordance with the instructions for use

Study Arms

: 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

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

168

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 30, 2019

Estimated Primary Completion Date

May 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

6 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Bitop AG

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Andreas Bilstein, Dr. CSO

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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