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

• ClinicalTrials.gov Identifier: NCT03480100
• Recruitment Status: Completed
• First Posted: March 29, 2018
• Last Update Posted: July 11, 2018
• 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, 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.

Condition or disease	Intervention/treatment
Acute Rhinosinusitis	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 Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Non-interventional Study to Investigate the Efficacy and Tolerability of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis
• Actual Study Start Date: November 27, 2017
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: May 31, 2018

Groups and Cohorts

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 Name: 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 Name: NasenSpray-ratiopharm Erwachsene (adults); Device: Ectoin Nasal Douche; Application of Ectoin Nasal Douche (END01) in accordance with the instructions for use; Other Name: END01

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. Assessment of the efficacy of treatments [ Time Frame: 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: day 7 or day 14 (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
• 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

Witten, NRW, Germany, 58453

Sponsors and Collaborators

Bitop AG

Investigators

• Study Director: Andreas Bilstein, Dr.; CSO

More Information

• Responsible Party: Bitop AG
• ClinicalTrials.gov Identifier: NCT03480100
• Other Study ID Numbers: PPL-106
• First Posted: March 29, 2018
• Last Update Posted: July 11, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Bitop AG:

rhinosinusitis; nasal irrigation; nasal douche; Ectoin

Additional relevant MeSH terms:

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