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

• ClinicalTrials.gov Identifier: NCT03693976
• Recruitment Status: Completed
• First Posted: October 3, 2018
• Last Update Posted: July 10, 2019
• Sponsor: Bitop AG
• Information provided by (Responsible Party): Bitop AG

Study Description

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.

Condition or disease	Intervention/treatment
Acute Rhinosinusitis	Drug: Xylometazoline Nasal Spray; Device: Ectoin Rhinosinusitis 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 Design

• Study Type: Observational
• Actual Enrollment: 168 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: 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.
• Actual Study Start Date: October 1, 2018
• Actual Primary Completion Date: April 15, 2019
• Actual Study Completion Date: April 15, 2019

Groups and Cohorts

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 Name: 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 Name: 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	Drug: Xylometazoline Nasal Spray; Application of Xylometazoline Nasal Spray in accordance with the instructions for use; Other Name: NasenSpray-ratiopharm Erwachsene (adults); Device: Ectoin Rhinosinusitis Nasal Spray; Application of Ectoin Nasal Spray (SNS01) in accordance with the instructions for use; Other Name: SNS01

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).
2. 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).
3. Investigators' and patients' assessment of 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).
4. Assessment of the tolerability of treatments [ Time Frame: once on day 7 or once on day 14 of treatment (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).
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 6 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients aged above 6 years diagnosed with acute viral rhinosinusitis

Criteria

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

Contacts and Locations

Locations

Germany

bitop AG

Dortmund, Germany, 44263

Sponsors and Collaborators

Bitop AG

Investigators

• Study Director: Andreas Bilstein, Dr.; CSO

More Information

• Responsible Party: Bitop AG
• ClinicalTrials.gov Identifier: NCT03693976
• Other Study ID Numbers: btph-010-2018-SNS01
• First Posted: October 3, 2018
• Last Update Posted: July 10, 2019
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Xylometazoline; Nasal Decongestants; Vasoconstrictor Agents; Respiratory System Agents