Non-interventional Study of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis

Non-interventional Study to Investigate the Efficacy and Tolerability of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis

The goal of this non interventional study is to investigate the efficacy, tolerability and safety of the newly developed Ectoin Nasal Douche END01. Within the study, END01 will be used as concomitant therapy in addition to the use of a Xylometazoline-containing decongestant nasal spray.

It will be investigated if the dosis of the used decongestant nasal spray might be reduced, the development of the disease might be positively influenced and/or the potentially occuring side effects (e.g. dryness of the nasal mucosa, sneezing) might be alleviated by using the Ectoin Nasal Douche as concomitant therapy.

Study Overview

• Status: Completed
• Conditions: Acute Rhinosinusitis
• Intervention / Treatment: Drug: Xylometazoline Nasal Spray; Device: Ectoin Nasal Douche

Detailed Description

The current non-interventional study aims to investigate the efficacy, tolerability and safety of a decongestant Xylometazoline-containing nasal spray in comparison to use of a decongestant Xylometazoline-containing nasal spray together with an Ectoin-containing nasal douche in patients with acute viral rhinosinusitis.

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: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Witten, NRW, Germany, 58453
      • bitop AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged above 6 years diagnosed with acute viral rhinosinusitis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: NasenSpray-ratiopharm Erwachsene (adults)
Xylometazoline + Ectoin Nasal Douche; Xylometazoline: 1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day, Ectoin Nasal Douche (END01): 1 spray per nostril 2-6 times per day or as often as required	Drug: Xylometazoline Nasal Spray; Application of Xylometazoline Nasal Spray in accordance with the instructions for use; Other Names: NasenSpray-ratiopharm Erwachsene (adults); Device: Ectoin Nasal Douche; Application of Ectoin Nasal Douche (END01) in accordance with the instructions for use; Other Names: END01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physicians' assessment of general well-being of patients	The investigators will assess the well-being of patients using a 4-point scale (good condition to strong illness).	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	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).	7 to 14 days (depending on study duration)
Incidence of adverse events/serious adverse events	All occurring adverse events/serious adverse events will be documented during the entire study period.	7 to 14 days (depending on study duration)
Assessment of the efficacy of treatments	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).	day 7 or day 14 (depending on study duration)
Assessment of the tolerability of treatments	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).	day 7 or day 14 (depending on study duration)

Collaborators and Investigators

• Sponsor: Bitop AG
• Investigators: Study Director: Andreas Bilstein, Dr., CSO

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: nasal irrigation; rhinosinusitis; Ectoin; nasal douche
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Respiratory System Agents; Vasoconstrictor Agents; Nasal Decongestants; Xylometazoline
• Other Study ID Numbers: PPL-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided