Clinical trial NCT04703673: Sinolpan® Pharmacy Non-interventional Study - Quality of Live
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinosinusitis Acute
Rhinosinusitis Chronic
Bronchitis
Keywords: Quality of Life
Lead sponsor: Engelhard Arzneimittel GmbH & Co.KG
Sponsor class: INDUSTRY
Collaborators: name: ClinCompetence Cologne GmbH
First posted: 2021-01-11
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with inflammatory diseases of the respiratory tract

Brief 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.

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.

Eligibility criteria: 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.

Exclusion Criteria:

* According to the instructions for use

Primary outcomes:
measure: Change in the Rhinosinusitis Quality of Life Score
timeFrame: Baseline (before first administration) and at day 10 resp. after end of treatment
Secondary outcomes:
measure: Bronchitis severity score (BSS)
timeFrame: Baseline (before first administration) and at day 10 resp. after end of treatment
measure: Number of adverse drug reactions
timeFrame: During the treatment period (maximum of 10 days)
measure: Tolerability of the Treatment score
timeFrame: Query on the last day of treatment (maximum day 10)
Other outcomes:
Locations:
city: Köln
country: Germany
facility: ClinCompetence Cologne GmbH
Study officials:
affiliation: ClinCompetence Cologne GmbH
name: Ralph Mösges, Prof
role: STUDY_DIRECTOR
References: