Sinolpan® Pharmacy Non-interventional Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-08

Study Completion Date

2022-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of ONO-1078 in Patients With Chronic Sinusitis

NCT00410735

Chronic Sinusitis

COMPLETED PHASE3

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

NCT01684540

Sinusitis

COMPLETED

Clinical Effect of Panfoxol of Otolaryngological Diseases of Upper Respiratory Tract Infection: A Multicenter Retrospective Observational Study

NCT05806086

Otologic Disease

COMPLETED NA

The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype

NCT04171167

Chronic Rhinosinusitis (Diagnosis)

ACTIVE_NOT_RECRUITING NA

Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis

NCT01146860

Acute Rhinosinusitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Rhinosinusitis Acute Rhinosinusitis Chronic Bronchitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Cineole

Intervention Type DRUG

self administration according to directions for use

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.

Nasal Decongestant

Intervention Type DRUG

self administration according to directions for use

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cineole

self administration according to directions for use

Intervention Type DRUG

Nasal Decongestant

self administration according to directions for use

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

nasally applied α-sympathomimetics

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.