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

NCT03693976 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 168

Last updated 2019-07-10

No results posted yet for this study

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.

Conditions

  • Acute Rhinosinusitis

Interventions

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

Sponsors & Collaborators

  • Bitop AG

    lead INDUSTRY

Principal Investigators

  • Andreas Bilstein, Dr. · CSO

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-04-15
Completion
2019-04-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03693976 on ClinicalTrials.gov