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NCT Number: NCT03480100

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

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.

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Key information

Conditions

Acute Rhinosinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinosinusitis Sinusitis

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

bitop AG

Witten, North Rhine-Westphalia, 58453, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xylometazoline Nasal Spray

Drug

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

Other names: NasenSpray-ratiopharm Erwachsene (adults)

Ectoin Nasal Douche

Device

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

Other names: END01

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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