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Completed

NCT Number: NCT01684540

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

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.

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Key information

Conditions

Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinosinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. med. Georg Krueckels, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical device, drug-like

Other

Ectoin Rhinitis Nasal Spray

Sinupret forte

Drug

Primary outcomes

  1. Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score

    Time frame: day 1, day 7, day 14

Secondary outcomes

  1. Quality of Life questionnaire (Rhino QoL)

    Time frame: day 1, day 7, day 14

  2. Rhinoscopy

    Time frame: day 1, day 7, day 14

  3. Patient's and physician's judgment of efficacy

    Time frame: day 7, day 14

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study title

Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis

Acronym: SNS01

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 13, 2012
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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