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

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ClinicalTrials.gov Identifier: NCT03480100
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bitop AG

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 Type : Observational
Estimated 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
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480100


Contacts
Contact: Andreas Bilstein, Dr. +49 (0)2302 9144040 bilstein@bitop.de
Contact: Nina Werkhäuser, Dr. +49 (0)2302 9144028 werkhaeuser@bitop.de

Locations
Germany
bitop AG Recruiting
Witten, NRW, Germany, 58453
Contact: Nina Werkhäuser, Dr.    +49 (0)2302 9144028    werkhaeuser@bitop.de   
Contact: Andreas Bilstein, Dr.    +49 (0)2302 9144040    bilstein@bitop.de   
Principal Investigator: Uwe Sonnemann, Dr.         
Sub-Investigator: Kathrin Mahlstedt, Dr.         
Sponsors and Collaborators
Bitop AG
Investigators
Study Director: Andreas Bilstein, Dr. CSO

Responsible Party: Bitop AG
ClinicalTrials.gov Identifier: NCT03480100     History of Changes
Other Study ID Numbers: PPL-106
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 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
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Xylometazoline
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents