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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

Tracking Information
First Submitted Date October 1, 2018
First Posted Date October 3, 2018
Last Update Posted Date July 10, 2019
Actual Study Start Date October 1, 2018
Actual Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 1, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03693976 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 5, 2018)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures
 (submitted: October 1, 2018)
  • 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).
  • 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).
  • Assessment of the 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).
  • Assessment of the tolerability of treatments [ Time Frame: once on 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).
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-interventional Study With Ectoin Containing and/or Decongesting Nasal Spray in Patients With Rhinosinusitis
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.
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.

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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients aged above 6 years diagnosed with acute viral rhinosinusitis
Condition Acute Rhinosinusitis
Intervention
  • 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
Study Groups/Cohorts
  • Ectoin Rhinosinusitis Nasal Spray
    application of 1-2 sprays of SNS01 into each nostril several times a day
    Intervention: Device: Ectoin Rhinosinusitis Nasal Spray
  • Xylometazoline nasal spray
    1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day
    Intervention: Drug: Xylometazoline Nasal Spray
  • 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
    Interventions:
    • Drug: Xylometazoline Nasal Spray
    • Device: Ectoin Rhinosinusitis Nasal Spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 1, 2018)
168
Original Estimated Enrollment Same as current
Actual Study Completion Date April 15, 2019
Actual Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03693976
Other Study ID Numbers btph-010-2018-SNS01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Bitop AG
Study Sponsor Bitop AG
Collaborators Not Provided
Investigators
Study Director: Andreas Bilstein, Dr. CSO
PRS Account Bitop AG
Verification Date November 2018