Ignite Creation Date:
2024-05-06 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03480100
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2017-11-30
Brief Title:
Non-interventional Study of Ectoin Nasal Douche END01 in Patients With Acute Viral Rhinosinusitis
Sponsor:
Bitop AG
Organization:
Bitop AG
Study Overview
Official Title:
Non-interventional Study to Investigate the Efficacy and Tolerability of Ectoin Nasal Douche END01 in Patients With Acute Viral Rhinosinusitis
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor the potentially occuring side effects eg dryness of the nasal mucosa sneezing might be alleviated by using the Ectoin Nasal Douche as concomitant therapy
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 andor the potentially occuring side effects eg 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 headacheface pain loss of sense of smelltaste
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
Efficacy will be studied by documentation of the following symptoms
oedema redness assessed by rhinoscopy
nasal obstruction nasal secretion headacheface pain loss of sense of smelltaste
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None