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

Bitop

Status: Completed

Conditions: Acute Rhinosinusitis

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03480100

PPL-106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 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

120 participants in 2 patient groups

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 Douche

Description:

Xylometazoline: 1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day, Ectoin Nasal Douche (END01): 1 spray per nostril 2-6 times per day or as often as required

Treatment:

Drug: Xylometazoline Nasal Spray

Device: Ectoin Nasal Douche