Sinolpan® Pharmacy Non-interventional Study - Quality of Live

NCT04703673 | Completed

• 1 other identifier: EA-20-01-996
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinosinusitis Acute; Rhinosinusitis Chronic; Bronchitis

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Bronchitis severity score (BSS)

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

• Number of adverse drug reactions

  During the treatment period (maximum of 10 days)

• Tolerability of the Treatment score

  Query on the last day of treatment (maximum day 10)

Study Arms (2)

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.

Drug: Cineole

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.

Drug: Nasal Decongestant

Interventions

Cineole DRUG

self administration according to directions for use

Sinolpan® group

Nasal Decongestant DRUG

self administration according to directions for use

Also known as: nasally applied α-sympathomimetics

Nasal spray group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with inflammatory diseases of the respiratory tract

You may qualify if:

• 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.

You may not qualify if:

• According to the instructions for use

Sponsors & Collaborators

• Engelhard Arzneimittel GmbH & Co.KG: lead
• ClinCompetence Cologne GmbH: collaborator

Study Sites (1)

ClinCompetence Cologne GmbH

Cologne, Germany

Location

MeSH Terms

Conditions

Bronchitis

Interventions

Eucalyptol; Nasal Decongestants

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids; Vasoconstrictor Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Respiratory System Agents

Study Officials

• Ralph Mösges, Prof

  ClinCompetence Cologne GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: January 11, 2021
• Study Start: January 8, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

DE (1)