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NCT Number: NCT04703673

Sinolpan® Pharmacy Non-interventional Study - Quality of Live

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.

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Key information

Conditions

Rhinosinusitis Acute Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Rhinosinusitis Chronic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ClinCompetence Cologne GmbH

Cologne, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cineole

Drug

self administration according to directions for use

Nasal Decongestant

Drug

self administration according to directions for use

Other names: nasally applied α-sympathomimetics

Primary outcomes

  1. 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.

Secondary outcomes

  1. Bronchitis severity score (BSS)

    Time frame: Baseline (before first administration) and at day 10 resp. after end of treatment

    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.

  2. Number of adverse drug reactions

    Time frame: During the treatment period (maximum of 10 days)

    Number of adverse drug reactions, the reported nature of ADR, the duration and the incidence of ADRs

  3. Tolerability of the Treatment score

    Time frame: Query on the last day of treatment (maximum day 10)

    Tolerability will be assessed by the participants by means of the following 4-point-tolerability score: very good, good, satisfactory, not satisfactory.

Sponsors and collaborators

Lead sponsor

Engelhard Arzneimittel GmbH & Co.KG

Industry

Collaborators

  • ClinCompetence Cologne GmbH

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2021
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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