Application of Ectoin® Rhinitis Nasal Spray in Patients W... | NCT01684540

Studies
Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis

NCT01684540

Sponsor

Bitop AG

Status

Completed

Last Update Posted

Jan 29, 2026Actual

Enrollment

66Actual

Phase

Not provided

Conditions

Sinusitis

Interventions

Medical Device, Drug-like
Sinupret forte

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NIS SNS01

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Sep 11, 2012

First Submission Date that Met QC Criteria

Sep 11, 2012

First Posted Date

Sep 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2026

Last Update Posted Date

Jan 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin® Rhinitis Nasal Spray. In addition the effectiveness and safety shall be compared to a Sinupret forte. The patient applies Ectoin® Rhinitis Nasal Spray or takes Sinupret forte according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a dairy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical Device, Drug-like	Other	Ectoin Rhinitis Nasal Spray
Sinupret forte	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score		day 1, day 7, day 14

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life questionnaire (Rhino QoL)		day 1, day 7, day 14
Rhinoscopy		day 1, day 7, day 14
Patient's and physician's judgment of efficacy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female or male individuals ≥ 18 years
Patients with acute Rhinosinusitis which are treated with Ectoin® Rhinitis Nasal Spray or Sinupret forte during the observational period

Exclusion Criteria:

Contra indications according to the label

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary Care Clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ralph Mösges, Prof.	Institut für Med. Informatik, Statistik und Epidemiologie	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. med. Georg Krueckels		Aachen			Germany
Dr. med. Martin Sondermann

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23621514	Derived	Eichel A, Wittig J, Shah-Hosseini K, Mosges R. A prospective, controlled study of SNS01 (ectoine nasal spray) compared to BNO-101 (phytotherapeutic dragees) in patients with acute rhinosinusitis. Curr Med Res Opin. 2013 Jul;29(7):739-46. doi: 10.1185/03007995.2013.800474. Epub 2013 May 14.

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010254	Paranasal Sinus Diseases
D009668	Nose Diseases

ID	Term
D012852	Sinusitis
D000096825	Rhinosinusitis