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

Acute Rhinosinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480100
• Other study ID #: PPL-106
• Status: Completed
• Start date: November 27, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: July 2018
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Rhinosinusitis
• Sinusitis

Intervention

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

Device:
• Ectoin Nasal Douche
Application of Ectoin Nasal Douche (END01) in accordance with the instructions for use

Locations

Country	Name	City	State
Germany	bitop AG	Witten	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)