Acute RhinosinusitisNCT03480100
Non-interventional Study of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis
An observational study of Acute Rhinosinusitis, run by Bitop AG at 1 site in Germany.
Trial summary
The goal of this non interventional study is to investigate the efficacy, tolerability and safety of the newly developed Ectoin Nasal Douche END01. Within the study, END01 will be used as concomitant therapy in addition to the use of a Xylometazoline-containing decongestant nasal spray. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Acute Rhinosinusitis
- What is being tested?
- Xylometazoline Nasal Spray and Ectoin Nasal Douche
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 27 Nov 2017to 31 May 2018
- 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 6 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients aged above 6 years diagnosed with acute viral rhinosinusitis
Who may be able to join
- patients with acute viral rhinosinusitis
- presence of common cold symptoms
Who cannot join
- contraindications in accordance with instructions for use
- acute bacterial rhinosinusitis
- chronic rhinosinusitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study to Investigate the Efficacy and Tolerability of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis
The goal of this non interventional study is to investigate the efficacy, tolerability and safety of the newly developed Ectoin Nasal Douche END01. Within the study, END01 will be used as concomitant therapy in addition to the use of a Xylometazoline-containing decongestant nasal spray.
It will be investigated if the dosis of the used decongestant nasal spray might be reduced, the development of the disease might be positively influenced and/or the potentially occuring side effects (e.g. dryness of the nasal mucosa, sneezing) might be alleviated by using the Ectoin Nasal Douche as concomitant therapy.
Read the detailed description
The current non-interventional study aims to investigate the efficacy, tolerability and safety of a decongestant Xylometazoline-containing nasal spray in comparison to use of a decongestant Xylometazoline-containing nasal spray together with an Ectoin-containing nasal douche in patients with acute viral rhinosinusitis.
Efficacy will be studied by documentation of the following symptoms:
- oedema, redness (assessed by rhinoscopy)
- nasal obstruction, nasal secretion, headache/face pain, loss of sense of smell/taste
- sore throat, cough
In parallel, participating patients will document their symptoms and the their quality of life over the entire study duration in patient diaries.
Patients of both genders aged 6 years and above can take part in the study if diagnosed with acute viral rhinosinusitis. The assignment of a patient to a particular treatment is not decided in advance but falls within current practice, and is clearly separated from the decision to include the patient into the study.
Study therapy will be applied in accordance with the respective instructions for use.
Study duration is 7-14 days, depending on the improvement of symptoms. At the end of the study, both the investigators and the patients are asked to judge the efficacy and tolerability of the treatments.
- Conditions
- Acute Rhinosinusitis
- Being tested
- Xylometazoline Nasal Spray, Ectoin Nasal Douche
- Keywords
- rhinosinusitis, nasal irrigation, nasal douche, Ectoin
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylometazoline Nasal SprayDrug
Also called NasenSpray-ratiopharm Erwachsene (adults)
Application of Xylometazoline Nasal Spray in accordance with the instructions for use
Ectoin Nasal DoucheDevice
Also called END01
Application of Ectoin Nasal Douche (END01) in accordance with the instructions for use
| Study group | Role | What they receive |
|---|---|---|
| Xylometazoline Nasal spray | 1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day Receives: Drug: Xylometazoline Nasal Spray | |
| Xylometazoline + Ectoin Nasal Douche | Xylometazoline: 1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day, Ectoin Nasal Douche (END01): 1 spray per nostril 2-6 times per day or as often as required Receives: Drug: Xylometazoline Nasal Spray; Device: Ectoin Nasal Douche |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physicians' assessment of change of intensity of rhinosinusitis symptoms
Both on day 0 and on day 7 (and, if necessary, depending on study duration, on day 14), the physicians will assess rhinosinusitis symptoms oedema, redness of the nose, nasal obstruction, nasal secretion, facial pain/headache, smell/taste dysfunction and the concomitant symptoms dryness of the nasal mucosa and sore throat. Assessment will be carried out based on a 5-point scale (0=none to 4=very strong). Change of symptoms will be assessed comparing symptom scores on day 7 (or day 14, if applicable) to day 0. The investigators will use rhinoscopy, physical examination and interview of the patients for the assessments.
Measured: day 0 and day 7 and (if necessary, depending on study duration) and on day 14
Secondary outcomes (5)
Physicians' assessment of general well-being of patients
The investigators will assess the well-being of patients using a 4-point scale (good condition to strong illness).
Measured: day 0 and day 7 and day 14 (if necessary, depending on study duration)
Patients' assessment of intensity of symptoms and their influence on quality of life
Patients will document their rhinosinusitis symptoms and their influence on quality of life (22 parameters in accordance with the "sino-nasal outcome test-22 questionnaire") and the additional symptom "dry nose". They will document their judgement daily in a patient diary using a 6-point scale (0=no problem to 5=as bad as possible).
Measured: 7 to 14 days (depending on study duration)
Assessment of the efficacy of treatments
At the end of the study, both investigators and patients will judge the overall efficacy of the treatment based on a 6-point scale (1=very good to 6=unsatisfactory).
Measured: day 7 or day 14 (depending on study duration)
Assessment of the tolerability of treatments
Both investigators and patients will judge the tolerability of the treatments at the end of the study. Both investigators and patients will judge the tolerability based on a 6 point scale (1=very good to 6 = unsatisfactory).
Measured: day 7 or day 14 (depending on study duration)
Incidence of adverse events/serious adverse events
All occurring adverse events/serious adverse events will be documented during the entire study period.
Measured: 7 to 14 days (depending on study duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start27 Nov 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute RhinosinusitisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Bilstein, Dr., Study director, CSO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480100
- Sponsor's protocol ID
- PPL-106
- Status last verified
- Jul 2018
- First submitted
- 30 Nov 2017
- Last updated
- 11 Jul 2018
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Investigate the Efficacy and Tolerability of Ectoin Nasal Douche (END01) in Patients With Acute Viral Rhinosinusitis
- ClinicalTrials.gov ID
- NCT03480100
- Acronym / sponsor ID
- PPL-106
- Conditions
- Acute Rhinosinusitis
- Keywords
- rhinosinusitis, nasal irrigation, nasal douche, Ectoin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 29 Mar 2018 (actual)
- 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.
The goal of this non interventional study is to investigate the efficacy, tolerability and safety of the newly developed Ectoin Nasal Douche END01. Within the study, END01 will be used as concomitant therapy in addition to the use of a Xylometazoline-containing decongestant nasal spray.
It will be investigated if the dosis of the used decongestant nasal spray might be reduced, the development of the disease might be positively influenced and/or the potentially occuring side effects (e.g. dryness of the nasal mucosa, sneezing) might be alleviated by using the Ectoin Nasal Douche as concomitant therapy.
Detailed description
The current non-interventional study aims to investigate the efficacy, tolerability and safety of a decongestant Xylometazoline-containing nasal spray in comparison to use of a decongestant Xylometazoline-containing nasal spray together with an Ectoin-containing nasal douche in patients with acute viral rhinosinusitis.
Efficacy will be studied by documentation of the following symptoms:
- oedema, redness (assessed by rhinoscopy)
- nasal obstruction, nasal secretion, headache/face pain, loss of sense of smell/taste
- sore throat, cough
In parallel, participating patients will document their symptoms and the their quality of life over the entire study duration in patient diaries.
Patients of both genders aged 6 years and above can take part in the study if diagnosed with acute viral rhinosinusitis. The assignment of a patient to a particular treatment is not decided in advance but falls within current practice, and is clearly separated from the decision to include the patient into the study.
Study therapy will be applied in accordance with the respective instructions for use.
Study duration is 7-14 days, depending on the improvement of symptoms. At the end of the study, both the investigators and the patients are asked to judge the efficacy and tolerability of the treatments.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylometazoline Nasal spray | – | Drug: Xylometazoline Nasal Spray1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day |
| Xylometazoline + Ectoin Nasal Douche | – | Drug: Xylometazoline Nasal Spray, Device: Ectoin Nasal DoucheXylometazoline: 1 spray per nostril as often as required but not exceeding 3 sprays per nostril per day, Ectoin Nasal Douche (END01): 1 spray per nostril 2-6 times per day or as often as required |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged above 6 years diagnosed with acute viral rhinosinusitis
Key inclusion criteria (2 listed)
- patients with acute viral rhinosinusitis
- presence of common cold symptoms
Key exclusion criteria (3 listed)
- contraindications in accordance with instructions for use
- acute bacterial rhinosinusitis
- chronic rhinosinusitis
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 |
|---|---|---|
| Xylometazoline Nasal SprayAlso: NasenSpray-ratiopharm Erwachsene (adults)Application of Xylometazoline Nasal Spray in accordance with the instructions for use | Drug | Xylometazoline + Ectoin Nasal Douche, Xylometazoline Nasal spray |
| Ectoin Nasal DoucheAlso: END01Application of Ectoin Nasal Douche (END01) in accordance with the instructions for use | Device | Xylometazoline + Ectoin Nasal Douche |
Primary outcome
Physicians' assessment of change of intensity of rhinosinusitis symptoms
Time frame: day 0 and day 7 and (if necessary, depending on study duration) and on day 14
Both on day 0 and on day 7 (and, if necessary, depending on study duration, on day 14), the physicians will assess rhinosinusitis symptoms oedema, redness of the nose, nasal obstruction, nasal secretion, facial pain/headache, smell/taste dysfunction and the concomitant symptoms dryness of the nasal mucosa and sore throat. Assessment will be carried out based on a 5-point scale (0=none to 4=very strong). Change of symptoms will be assessed comparing symptom scores on day 7 (or day 14, if applicable) to day 0. The investigators will use rhinoscopy, physical examination and interview of the patients for the assessments.
5 secondary outcomes
Physicians' assessment of general well-being of patients
Time frame: day 0 and day 7 and day 14 (if necessary, depending on study duration)
Patients' assessment of intensity of symptoms and their influence on quality of life
Time frame: 7 to 14 days (depending on study duration)
Assessment of the efficacy of treatments
Time frame: day 7 or day 14 (depending on study duration)
Assessment of the tolerability of treatments
Time frame: day 7 or day 14 (depending on study duration)
Incidence of adverse events/serious adverse events
Time frame: 7 to 14 days (depending on study duration)
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 11 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Andreas Bilstein, Dr. study director
CSO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Rhinosinusitis, run by Bitop AG at 1 site 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 3 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 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Physicians' assessment of change of intensity of rhinosinusitis symptoms (time frame: day 0 and day 7 and (if necessary, depending on study duration) and on day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2018.