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

NCT ID: NCT01684540

Last Updated: 2012-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Sinusitis

Keywords

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sinusitis, rhinosinusitis, ectoin, ectoine, bitop, SNS, SNS01

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Medical Device, Drug-like

Ectoin Rhinitis Nasal Spray

Intervention Type OTHER

Sinupret forte

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bitop AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ralph Mösges, Prof.

Role: STUDY_DIRECTOR

Institut für Med. Informatik, Statistik und Epidemiologie

Locations

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Dr. med. Georg Krueckels

Aachen, , Germany

Site Status

Dr. med. Martin Sondermann

Aachen, , Germany

Site Status

Dr. med. Norbert Pasch

Aachen, , Germany

Site Status

Peter Hinterkausen

Cologne, , Germany

Site Status

Taufik Shahab

Cologne, , Germany

Site Status

Dr. med. Wilhelm Schuetz

Jülich, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 23621514 (View on PubMed)

Other Identifiers

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NIS SNS01

Identifier Type: -

Identifier Source: secondary_id

PPL-047

Identifier Type: -

Identifier Source: org_study_id