Clinical trial NCT03480100: Non-interventional Study of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis
Official title: Non-interventional Study to Investigate the Efficacy and Tolerability of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Rhinosinusitis
Keywords: rhinosinusitis
nasal irrigation
nasal douche
Ectoin
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged above 6 years diagnosed with acute viral rhinosinusitis

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.

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.

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

Primary outcomes:
measure: Physicians' assessment of change of intensity of rhinosinusitis symptoms
timeFrame: day 0 and day 7 and (if necessary, depending on study duration) and on day 14
Secondary outcomes:
measure: Physicians' assessment of general well-being of patients
timeFrame: day 0 and day 7 and day 14 (if necessary, depending on study duration)
measure: Patients' assessment of intensity of symptoms and their influence on quality of life
timeFrame: 7 to 14 days (depending on study duration)
measure: Assessment of the efficacy of treatments
timeFrame: day 7 or day 14 (depending on study duration)
measure: Assessment of the tolerability of treatments
timeFrame: day 7 or day 14 (depending on study duration)
measure: Incidence of adverse events/serious adverse events
timeFrame: 7 to 14 days (depending on study duration)
Other outcomes:
Locations:
city: Witten
country: Germany
facility: bitop AG
state: NRW
Study officials:
affiliation: CSO
name: Andreas Bilstein, Dr.
role: STUDY_DIRECTOR
References: