Sinolpan® Pharmacy Non-interventional Study - Quality of Live

Bronchitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04703673
• Other study ID #: EA-20-01-996
• Status: Completed
• Start date: January 8, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: October 2022
• Source: Engelhard Arzneimittel GmbH & Co.KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a-sympathomimetics for therapy.

Exclusion Criteria:

• According to the instructions for use

Related Conditions & MeSH terms

• Bronchitis
• Rhinosinusitis Acute
• Rhinosinusitis Chronic
• Sinusitis

Intervention

Drug:
• Cineole
self administration according to directions for use
• Nasal Decongestant
self administration according to directions for use

Locations

Country	Name	City	State
Germany	ClinCompetence Cologne GmbH	Köln

Sponsors (2)

Lead Sponsor	Collaborator
Engelhard Arzneimittel GmbH & Co.KG	ClinCompetence Cologne GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (before first administration) and at day 10 resp. after end of treatment
Secondary	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.	Baseline (before first administration) and at day 10 resp. after end of treatment
Secondary	Number of adverse drug reactions	Number of adverse drug reactions, the reported nature of ADR, the duration and the incidence of ADRs	During the treatment period (maximum of 10 days)
Secondary	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.	Query on the last day of treatment (maximum day 10)