Rhinosinusitis AcuteNCT04703673
Sinolpan® Pharmacy Non-interventional Study - Quality of Live
An observational study of Rhinosinusitis Acute and Rhinosinusitis Chronic, run by Engelhard Arzneimittel GmbH & Co.KG at 1 site in Germany.
Trial summary
This non-interventional study investigates the Quality of Life of patients suffering from rhinosinusitis. Patients who seek advice in a pharmacy and choose to intake Sinolpan® or Sinolpan® forte or to use nasally applied α-sympathomimetics can participate in this anonymous patient survey. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinosinusitis Acute, Rhinosinusitis Chronic, Bronchitis
- What is being tested?
- Cineole and Nasal Decongestant
- How many people
- 350 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jan 2021to 30 Apr 2022
- 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: Patients with inflammatory diseases of the respiratory tract
Who may be able to join
- Suitable patients for the Sinolpan® group are patients aged 18 years or older who seek advice from a pharmacy regarding the treatment of their acute or chronic (rhino) sinusitis and, where appropriate, their bronchitis and who choose the intake of Sinolpan® (forte) for therapy.
- Suitable patients for the control group are patients aged 18 years or older who seek advice from a pharmacy regarding the treatment of their acute or chronic (rhino) sinusitis and who choose to apply nasal α-sympathomimetics for therapy.
Who cannot join
- According to the instructions for use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study on the Quality of Life Before and After Intake of Sinolpan® (Forte) in Inflammatory Diseases of the Respiratory Tract - an Anonymous Patient Survey
This non-interventional study investigates the Quality of Life of patients suffering from rhinosinusitis. Patients who seek advice in a pharmacy and choose to intake Sinolpan® or Sinolpan® forte or to use nasally applied α-sympathomimetics can participate in this anonymous patient survey.
Read the detailed description
Within the scope of this non-interventional observational study, the quality of life of rhinosinusitis patients under self-medication with the 1,8 - cineole preparation Sinolpan® or Sinolpan® forte (Sinolpan® group) or with a nasally applied α-sympathomimetic (control group) is investigated during conditions of daily life. Patients who seek advice from a pharmacy regarding the treatment of their symptoms and who choose Sinolpan® (forte) or a nasal α-sympathomimetic can participate in this study and are asked to complete a questionnaire before and after the treatment. For organizational reasons, the recruitment of patients for the Sinolpan® group (planned number of patients: 500) or the control group (planned number of patients: 50) is conducted in different pharmacies.
The primary objective of this anonymous data collection is to assess the quality of life in patients with rhinosinusitis. The German version of the Rhinosinusitis Quality of Life questionnaire, which was only recently validated in a doctoral thesis, is used for this purpose. Additionally, for patients in the Sinolpan® group who also suffer from bronchitis, the bronchitis severity score is determined. In addition, data on side effects and tolerability of the treatment as well as on patients' satisfaction are collected.
- Conditions
- Rhinosinusitis Acute, Rhinosinusitis Chronic, Bronchitis
- Being tested
- Cineole, Nasal Decongestant
- Keywords
- Quality of Life
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CineoleDrug
self administration according to directions for use
Nasal DecongestantDrug
Also called nasally applied α-sympathomimetics
self administration according to directions for use
| Study group | Role | What they receive |
|---|---|---|
| Sinolpan® group | Sinolpan® group: patients suffering from rhinosinusitis and, where appropriate, from bronchitis; intake of Sinolpan® 100 mg or Sinolpan® forte 200 mg (cineol) according to the instructions for use; before and after treatment for rhinosinusitis and, where appropriate, from bronchitis, patients complete a questionnaire that contains the Rhinosinusitis Quality of Life questionnaire and Questions about the severity of bronchitis symptoms. The latter should only be answered by patients who suffer from bronchitis in addition to rhinosinusitis. Receives: Drug: Cineole | |
| Nasal spray group | Control group: patients with rhinosinusitis; Use of nasal decongestants according to the instructions for use. Before and after treatment for rhinosinusitis, patients complete a questionnaire that includes the Rhinosinusitis Quality of Life questionnaire. Receives: Drug: Nasal Decongestant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Rhinosinusitis Quality of Life Score
The Rhinosinusitis Quality of Life is a validated questionnaire (Atlas et al., Qual Life Res 2005, 14, 1375-1386). It includes 5 symptom severity items (sinus headache/facial pain/facial pressure, blocked or stuffy nose, post-nasal drip, thick nasal discharge, runny nose).
It also includes 9 symptom impact items (tired or fatigued, trouble sleeping, harder to concentrate, harder to do the things you normally do, embarrassed, frustrated, irritable, sad or depressed, think about).
The score of the frequency of severity items and the score of the symptom impact items covers a Likert-scale: 1 to 5 with 1 = none of the time, 2= a little of the time, 3 = some of the time, 4 = most of the time and 5 = all of the time.
The score of the bothersomeness covers a scale from (not bothered at all) to 10 (bothered a lot).
The sum values of the individual subscores are normalised towards 100, resulting in values between 0 and 100.
Measured: Baseline (before first administration) and at day 10 resp. after end of treatment
Secondary outcomes (3)
Bronchitis severity score (BSS)
For patients suffering additionally from bronchitis: severity of bronchitis Symptoms
The BSS comprises the following five symptoms typical for acute bronchitis:
cough, sputum, rales on auscultation, chest pain on coughing, and dyspnoea. These symptoms are each assessed according to a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe. The points allocated to each of the symptoms are added to make the total score. This can therefore vary between 0 and 20 points and should show a one-dimensional degree of severity in the clinical signs of acute bronchitis.
Measured: Baseline (before first administration) and at day 10 resp. after end of treatment
Number of adverse drug reactions
Number of adverse drug reactions, the reported nature of ADR, the duration and the incidence of ADRs
Measured: During the treatment period (maximum of 10 days)
Tolerability of the Treatment score
Tolerability will be assessed by the participants by means of the following 4-point-tolerability score: very good, good, satisfactory, not satisfactory.
Measured: Query on the last day of treatment (maximum day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start8 Jan 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinosinusitis AcuteStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Engelhard Arzneimittel GmbH & Co.KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinCompetence Cologne GmbH
- Responsible party
- Sponsor
- Investigators
- Ralph Mösges, Prof, Study director, ClinCompetence Cologne GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703673
- Sponsor's protocol ID
- EA-20-01-996
- Status last verified
- Oct 2022
- First submitted
- 17 Dec 2020
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study on the Quality of Life Before and After Intake of Sinolpan® (Forte) in Inflammatory Diseases of the Respiratory Tract - an Anonymous Patient Survey
- ClinicalTrials.gov ID
- NCT04703673
- Acronym / sponsor ID
- EA-20-01-996
- Conditions
- Rhinosinusitis Acute, Rhinosinusitis Chronic, Bronchitis
- Keywords
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Engelhard Arzneimittel GmbH & Co.KGIndustry (pharma, biotech, devices)
- Collaborators
- ClinCompetence Cologne GmbH
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 11 Jan 2021 (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.
This non-interventional study investigates the Quality of Life of patients suffering from rhinosinusitis. Patients who seek advice in a pharmacy and choose to intake Sinolpan® or Sinolpan® forte or to use nasally applied α-sympathomimetics can participate in this anonymous patient survey.
Detailed description
Within the scope of this non-interventional observational study, the quality of life of rhinosinusitis patients under self-medication with the 1,8 - cineole preparation Sinolpan® or Sinolpan® forte (Sinolpan® group) or with a nasally applied α-sympathomimetic (control group) is investigated during conditions of daily life. Patients who seek advice from a pharmacy regarding the treatment of their symptoms and who choose Sinolpan® (forte) or a nasal α-sympathomimetic can participate in this study and are asked to complete a questionnaire before and after the treatment. For organizational reasons, the recruitment of patients for the Sinolpan® group (planned number of patients: 500) or the control group (planned number of patients: 50) is conducted in different pharmacies.
The primary objective of this anonymous data collection is to assess the quality of life in patients with rhinosinusitis. The German version of the Rhinosinusitis Quality of Life questionnaire, which was only recently validated in a doctoral thesis, is used for this purpose. Additionally, for patients in the Sinolpan® group who also suffer from bronchitis, the bronchitis severity score is determined. In addition, data on side effects and tolerability of the treatment as well as on patients' satisfaction are collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinolpan® group | – | Drug: CineoleSinolpan® group: patients suffering from rhinosinusitis and, where appropriate, from bronchitis; intake of Sinolpan® 100 mg or Sinolpan® forte 200 mg (cineol) according to the instructions for use; before and after treatment for rhinosinusitis and, where appropriate, from bronchitis, patients complete a questionnaire that contains the Rhinosinusitis Quality of Life questionnaire and Questions about the severity of bronchitis symptoms. The latter should only be answered by patients who suffer from bronchitis in addition to rhinosinusitis. |
| Nasal spray group | – | Drug: Nasal DecongestantControl group: patients with rhinosinusitis; Use of nasal decongestants according to the instructions for use. Before and after treatment for rhinosinusitis, patients complete a questionnaire that includes the Rhinosinusitis Quality of Life questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inflammatory diseases of the respiratory tract
Key inclusion criteria (2 listed)
- Suitable patients for the Sinolpan® group are patients aged 18 years or older who seek advice from a pharmacy regarding the treatment of their acute or chronic (rhino) sinusitis and, where appropriate, their bronchitis and who choose the intake of Sinolpan® (forte) for therapy.
- Suitable patients for the control group are patients aged 18 years or older who seek advice from a pharmacy regarding the treatment of their acute or chronic (rhino) sinusitis and who choose to apply nasal α-sympathomimetics for therapy.
Key exclusion criteria (1 listed)
- According to the instructions for use
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 |
|---|---|---|
| Cineoleself administration according to directions for use | Drug | Sinolpan® group |
| Nasal DecongestantAlso: nasally applied α-sympathomimeticsself administration according to directions for use | Drug | Nasal spray group |
Primary outcome
Change in the Rhinosinusitis Quality of Life Score
Time frame: Baseline (before first administration) and at day 10 resp. after end of treatment
The Rhinosinusitis Quality of Life is a validated questionnaire (Atlas et al., Qual Life Res 2005, 14, 1375-1386). It includes 5 symptom severity items (sinus headache/facial pain/facial pressure, blocked or stuffy nose, post-nasal drip, thick nasal discharge, runny nose). It also includes 9 symptom impact items (tired or fatigued, trouble sleeping, harder to concentrate, harder to do the things you normally do, embarrassed, frustrated, irritable, sad or depressed, think about). The score of the frequency of severity items and the score of the symptom impact items covers a Likert-scale: 1 to 5 with 1 = none of the time, 2= a little of the time, 3 = some of the time, 4 = most of the time and 5 = all of the time. The score of the bothersomeness covers a scale from (not bothered at all) to 10 (bothered a lot). The sum values of the individual subscores are normalised towards 100, resulting in values between 0 and 100.
3 secondary outcomes
Bronchitis severity score (BSS)
Time frame: Baseline (before first administration) and at day 10 resp. after end of treatment
Number of adverse drug reactions
Time frame: During the treatment period (maximum of 10 days)
Tolerability of the Treatment score
Time frame: Query on the last day of treatment (maximum day 10)
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 12 Oct 2022.
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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
ClinCompetence Cologne GmbH
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 Rhinosinusitis Acute and Rhinosinusitis Chronic, run by Engelhard Arzneimittel GmbH & Co.KG 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 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 12 Oct 2022. 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?
Change in the Rhinosinusitis Quality of Life Score (time frame: Baseline (before first administration) and at day 10 resp. after end of treatment). 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 12 Oct 2022.