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

Bitop

Status: Completed

Conditions: Acute Rhinosinusitis

Treatments: Device: Ectoin Rhinosinusitis Nasal Spray; Drug: Xylometazoline Nasal Spray

Study type: Observational

Funder types: Industry

Identifiers

NCT03693976

btph-010-2018-SNS01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

168 participants in 3 patient groups

Ectoin Rhinosinusitis Nasal Spray

Description:

application of 1-2 sprays of SNS01 into each nostril several times a day

Treatment:

Device: Ectoin Rhinosinusitis Nasal Spray

Xylometazoline nasal spray

Description:

1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day

Treatment:

Drug: Xylometazoline Nasal Spray

Xylometazoline + Ectoin Nasal Spray

Description:

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

Treatment:

Drug: Xylometazoline Nasal Spray

Device: Ectoin Rhinosinusitis Nasal Spray