Completed

SNS01Ectoin® Rhinitis Nasal Spray Effectiveness and Tolerability in Acute Rhinosinusitis

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Study Aim

This study observes the effectiveness and tolerability of Ectoin® Rhinitis Nasal Spray in alleviating symptoms of acute Rhinosinusitis, as measured by the EPOS- Sinusitis-Symptom-Score.

What is being collected

Data Collection

+ drug Data

Collected from today forward - Prospective
OtherDrug
Who is being recruted

Infections+6

+ Nose Diseases

+ Otorhinolaryngologic Diseases

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: February 2012
See protocol details

Summary

Principal SponsorBitop AG
Last updated: January 29, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2012

Actual date on which the first participant was enrolled.

This study focuses on comparing the effectiveness and safety of Ectoin® Rhinitis Nasal Spray and Sinupret forte in patients with Acute Rhinosinusitis, a condition that causes inflammation in the sinuses. The goal is to further understand how well these treatments work and how well they are tolerated by patients. This research is important as it can help improve care for those suffering from this condition by providing more insights on the best treatment options. During this 14-day study, participants will either use Ectoin® Rhinitis Nasal Spray or take Sinupret forte as per the provided instructions. The response to treatment is monitored by both the physician and the patient. The physician will assess the patient's condition on the 7th and 14th day, while the patient will keep a daily diary of their symptoms. The main outcome measured is the change in the symptoms of Acute Rhinosinusitis, evaluated using the EPOS- Sinusitis-Symptom-Score.

NCT01684540
Principal SponsorBitop AG
Last updated: January 29, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

66 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsNose DiseasesOtorhinolaryngologic DiseasesParanasal Sinus DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsRhinitisRhinosinusitisSinusitis

Criteria

2 inclusion criteria required to participate
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
1 exclusion criteria prevent from participating
Contra indications according to the label

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Dr. med. Georg Krueckels

Aachen, GermanyOpen Dr. med. Georg Krueckels in Google Maps

Dr. med. Martin Sondermann

Aachen, Germany

Dr. med. Norbert Pasch

Aachen, Germany

Peter Hinterkausen

Cologne, Germany
Completed6 Study Centers