Pharmacy based non-interventional study (NIS) assessing the efficacy and safety of Esberitox® COMPACT in case of colds

• Conditions: Viral cold diseases; J06.9; Acute upper respiratory infection, unspecified

• Registration Number: DRKS00011068
• Lead Sponsor: Schaper & Brümmer GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-21
• Study Completion: 2017-05-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 960

Inclusion Criteria

Patients who intend to treat their acute cold with Esberitox® COMPACT in line with the package information leaflet and who are invited by the pharmacist / the qualified staff to participate in the study.
- Written data collection consent has been obtained.

Exclusion Criteria

Contraindications of Esberitox® COMPACT according to the package information leaflet.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the risk-benefit ratio of Esberitox® COMPACT under everyday conditions by using a cold diary and by<br>- collection of essential cold symptoms (global cold; rhinitis score; bronchitis score; general complaints; total score) at treatment start and every 1 – 2 days during the maximum 10-day treatment and of the overall assessment of efficacy after the last application by the patient ('benefit')<br>- collection of adverse drug reactions during the course of treatment and of the overall assessment of tolerability after the last application by the patient ('risk').<br>

Secondary Outcome Measures

Name	Time	Method
Collection of the overall assessment of patient satisfaction with the treatment after the last application by using a cold diary.