Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03693976
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Bitop AG

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.


Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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): NCT03693976


Locations
Layout table for location information
Germany
bitop AG
Dortmund, Germany, 44263
Sponsors and Collaborators
Bitop AG
Investigators
Layout table for investigator information
Study Director: Andreas Bilstein, Dr. CSO

Layout table for additonal information
Responsible Party: Bitop AG
ClinicalTrials.gov Identifier: NCT03693976     History of Changes
Other Study ID Numbers: btph-010-2018-SNS01
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Xylometazoline
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents