NCT04703673

Sinolpan® Pharmacy Non-interventional Study - Quality of Live

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 350 (actual)
• Sponsor: Engelhard Arzneimittel GmbH & Co.KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinosinusitis Acute
• Rhinosinusitis Chronic
• Bronchitis

Interventions

Type	Name	Description
DRUG	Cineole	self administration according to directions for use
DRUG	Nasal Decongestant	self administration according to directions for use

Timeline

• Start date: 2021-01-08
• Primary completion: 2022-04-30
• Completion: 2022-04-30
• First posted: 2021-01-11
• Last updated: 2022-10-12

Locations

1 site across 1 country: Germany