Non-interventional Study With Ectoin Containing and/or Decongesting Nasal Spray in Patients With Rhinosinusitis
NCT ID: NCT03693976
Last Updated: 2019-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
168 participants
OBSERVATIONAL
2018-10-01
2019-04-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Ectoin Rhinosinusitis Nasal Spray
application of 1-2 sprays of SNS01 into each nostril several times a day
Ectoin Rhinosinusitis Nasal Spray
Application of Ectoin Nasal Spray (SNS01) in accordance with the instructions for use
Xylometazoline nasal spray
1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day
Xylometazoline Nasal Spray
Application of Xylometazoline Nasal Spray in accordance with the instructions for use
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
Xylometazoline Nasal Spray
Application of Xylometazoline Nasal Spray in accordance with the instructions for use
Ectoin Rhinosinusitis Nasal Spray
Application of Ectoin Nasal Spray (SNS01) in accordance with the instructions for use
Interventions
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Xylometazoline Nasal Spray
Application of Xylometazoline Nasal Spray in accordance with the instructions for use
Ectoin Rhinosinusitis Nasal Spray
Application of Ectoin Nasal Spray (SNS01) in accordance with the instructions for use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* presence of common cold symptoms
Exclusion Criteria
* acute bacterial rhinosinusitis
* chronic rhinosinusitis
6 Years
ALL
No
Sponsors
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Bitop AG
INDUSTRY
Responsible Party
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Principal Investigators
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Andreas Bilstein, Dr.
Role: STUDY_DIRECTOR
CSO
Locations
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bitop AG
Dortmund, , Germany
Countries
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References
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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.
Other Identifiers
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btph-010-2018-SNS01
Identifier Type: -
Identifier Source: org_study_id
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