SinusitisSNS01NCT01684540
Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis
An observational study of Sinusitis, run by Bitop AG at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis
- What is being tested?
- Medical Device, Drug-like and Sinupret forte
- How many people
- 66 participants
- Where
- 6 sitesGermany
- Study dates
- Feb 2012to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- 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
Who cannot join
- Contra indications according to the label
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Dr. med. Georg Krueckels
Aachen
Dr. med. Martin Sondermann
Aachen
Dr. med. Norbert Pasch
Aachen
Peter Hinterkausen
Cologne
Taufik Shahab
Cologne
Dr. med. Wilhelm Schuetz
Jülich
About this study
Official title: Non-interventional Study: 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.
- Conditions
- Sinusitis
- Being tested
- Medical Device, Drug-like, Sinupret forte
- Keywords
- sinusitis, rhinosinusitis, ectoin, ectoine, bitop, SNS, SNS01
- Medical subject headings
- Sinusitis, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device, Drug-likeOther
Ectoin Rhinitis Nasal Spray
Sinupret forteDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score
Measured: day 1, day 7, day 14
Secondary outcomes (3)
Quality of Life questionnaire (Rhino QoL)
Measured: day 1, day 7, day 14
Rhinoscopy
Measured: day 1, day 7, day 14
Patient's and physician's judgment of efficacy
Measured: day 7, day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Mösges, Prof., Study director, Institut für Med. Informatik, Statistik und Epidemiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684540
- Sponsor's protocol ID
- PPL-047
- Other IDs
- NIS SNS01
- Acronym
- SNS01
- Status last verified
- Jan 2026
- First submitted
- 11 Sep 2012
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23621514
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis
- ClinicalTrials.gov ID
- NCT01684540
- Acronym / sponsor ID
- SNS01 / PPL-047
- Conditions
- Sinusitis
- Keywords
- sinusitis, rhinosinusitis, ectoin, ectoine, bitop, SNS, SNS01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Contra indications according to the label
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Device, Drug-likeEctoin Rhinitis Nasal Spray | Other | – |
| Sinupret forte | Drug | – |
Primary outcome
Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score
Time frame: day 1, day 7, day 14
3 secondary outcomes
Quality of Life questionnaire (Rhino QoL)
Time frame: day 1, day 7, day 14
Rhinoscopy
Time frame: day 1, day 7, day 14
Patient's and physician's judgment of efficacy
Time frame: day 7, day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Derived from this study: PubMed 23621514Eichel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Mösges, Prof. study director
Institut für Med. Informatik, Statistik und Epidemiologie
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinusitis, run by Bitop AG at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score (time frame: day 1, day 7, day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01684540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.