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

NCT03693976 | Completed

• 1 other identifier: btph-010-2018-SNS01
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Physicians' assessment of general well-being of patients

  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

  7 to 14 days (depending on study duration)

• Investigators' and patients' assessment of efficacy of treatments

  once on day 7 or day 14 (depending on study duration)

• Assessment of the tolerability of treatments

  once on day 7 or once on day 14 of treatment (depending on study duration)

• Incidence of adverse events/serious adverse events

  7 to 14 days (depending on study duration)

Study Arms (3)

Ectoin Rhinosinusitis Nasal Spray

application of 1-2 sprays of SNS01 into each nostril several times a day

Device: Ectoin Rhinosinusitis Nasal Spray

Xylometazoline nasal spray

1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day

Drug: Xylometazoline Nasal Spray

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

Drug: Xylometazoline Nasal Spray; Device: Ectoin Rhinosinusitis Nasal Spray

Interventions

Xylometazoline Nasal Spray DRUG

Application of Xylometazoline Nasal Spray in accordance with the instructions for use

Also known as: NasenSpray-ratiopharm Erwachsene (adults)

Xylometazoline + Ectoin Nasal Spray; Xylometazoline nasal spray

Ectoin Rhinosinusitis Nasal Spray DEVICE

Application of Ectoin Nasal Spray (SNS01) in accordance with the instructions for use

Also known as: SNS01

Ectoin Rhinosinusitis Nasal Spray; Xylometazoline + Ectoin Nasal Spray

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged above 6 years diagnosed with acute viral rhinosinusitis

You may qualify if:

• patients with acute viral rhinosinusitis
• presence of common cold symptoms

You may not qualify if:

• contraindications in accordance with instructions for use
• acute bacterial rhinosinusitis
• chronic rhinosinusitis

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (1)

bitop AG

Dortmund, 44263, Germany

Location

Related Publications (1)

• 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.

  PMID: 34089097 DERIVED

Study Officials

• Andreas Bilstein, Dr.

  CSO

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: October 1, 2018
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: July 10, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)